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Section 882.1
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Effective dates of requirement for premarket approval |
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Section 882.3
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Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act) |
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Section 882.9
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Rigidity analyzer |
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Section 882.1020
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Ataxiagraph |
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Section 882.1030
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Two-point discriminator |
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Section 882.1200
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Echoencephalograph |
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Section 882.1240
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Electroconductive media |
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Section 882.1275
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Cortical electrode |
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Section 882.1310
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Cutaneous electrode |
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Section 882.1320
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Depth electrode |
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Section 882.1330
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Nasopharyngeal electrode |
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Section 882.1340
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Needle electrode |
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Section 882.1350
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Electroencephalograph |
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Section 882.1400
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Electroencephalograph electrode/lead tester |
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Section 882.1410
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Electroencephalogram (EEG) signal spectrum analyzer |
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Section 882.1420
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Electroencephalograph test signal generator |
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Section 882.1430
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Neuropsychiatric interpretive electroencephalograph assessment aid |
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Section 882.1440
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Brain injury adjunctive interpretive electroencephalograph assessment aid |
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Section 882.1450
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Nystagmograph |
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Section 882.1460
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Neurological endoscope |
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Section 882.1480
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Esthesiometer |
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Section 882.1500
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Tuning fork |
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Section 882.1525
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Galvanic skin response measurement device |
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Section 882.1540
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Nerve conduction velocity measurement device |
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Section 882.1550
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Skin potential measurement device |
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Section 882.1560
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Powered direct-contact temperature measurement device |
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Section 882.1570
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Alpha monitor |
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Section 882.1610
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Intracranial pressure monitoring device |
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Section 882.1620
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Percussor |
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Section 882.1700
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Pinwheel |
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Section 882.1750
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Ocular plethysmograph |
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Section 882.1790
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Rheoencephalograph |
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Section 882.1825
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Physiological signal amplifier |
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Section 882.1835
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Physiological signal conditioner |
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Section 882.1845
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Electroencephalogram (EEG) telemetry system |
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Section 882.1855
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Evoked response electrical stimulator |
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Section 882.1870
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Evoked response mechanical stimulator |
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Section 882.1880
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Evoked response photic stimulator |
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Section 882.1890
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Evoked response auditory stimulator |
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Section 882.1900
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Ultrasonic scanner calibration test block |
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Section 882.1925
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Near Infrared (NIR) Brain Hematoma Detector |
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Section 882.1935
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Tremor transducer |
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Section 882.1950
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Skull plate anvil |
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Section 882.4030
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Ventricular cannula |
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Section 882.4060
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Ventricular catheter |
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Section 882.4100
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Neurosurgical chair |
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Section 882.4125
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Scalp clip |
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Section 882.4150
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Aneurysm clip applier |
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Section 882.4175
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Clip forming/cutting instrument |
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Section 882.4190
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Clip removal instrument |
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Section 882.4200
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Clip rack |
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Section 882.4215
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Cryogenic surgical device |
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Section 882.4250
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Dowel cutting instrument |
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Section 882.4275
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Manual cranial drills, burrs, trephines, and their accessories |
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Section 882.4300
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Powered compound cranial drills, burrs, trephines, and their accessories |
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Section 882.4305
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Powered simple cranial drills, burrs, trephines, and their accessories |
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Section 882.4310
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Cranial drill handpiece (brace) |
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Section 882.4325
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Electric cranial drill motor |
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Section 882.4360
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Pneumatic cranial drill motor |
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Section 882.4370
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Radiofrequency lesion generator |
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Section 882.4400
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Neurosurgical headrests |
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Section 882.4440
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Neurosurgical head holder (skull clamp) |
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Section 882.4460
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Cranioplasty material forming instrument |
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Section 882.4500
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Microsurgical instrument |
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Section 882.4525
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Nonpowered neurosurgical instrument |
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Section 882.4535
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Shunt system implantation instrument |
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Section 882.4545
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Stereotaxic instrument |
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Section 882.4560
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Leukotome |
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Section 882.4600
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Neurosurgical suture needle |
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Section 882.4650
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Neurosurgical paddie |
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Section 882.4700
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Radiofrequency lesion probe |
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Section 882.4725
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Skull punch |
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Section 882.4750
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Self-retaining retractor for neurosurgery |
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Section 882.4800
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Manual rongeur |
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Section 882.4840
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Powered rongeur |
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Section 882.4845
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Skullplate screwdriver |
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Section 882.4900
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Methyl methacrylate for aneurysmorrhaphy |
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Section 882.5030
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Biofeedback device |
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Section 882.5050
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Bite block |
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Section 882.5070
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Intravascular occluding catheter |
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Section 882.5150
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Carotid artery clamp |
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Section 882.5175
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Aneurysm clip |
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Section 882.5200
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Implanted malleable clip |
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Section 882.5225
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Aversive conditioning device |
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Section 882.5235
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Burr hole cover |
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Section 882.5250
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Nerve cuff |
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Section 882.5275
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Methyl methacrylate for cranioplasty |
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Section 882.5300
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Preformed alterable cranioplasty plate |
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Section 882.5320
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Preformed nonalterable cranioplasty plate |
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Section 882.5330
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Cranioplasty plate fastener |
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Section 882.5360
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Lesion temperature monitor |
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Section 882.5500
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Central nervous system fluid shunt and components |
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Section 882.5550
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Cranial electrotherapy stimulator |
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Section 882.5800
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Repetitive transcranial magnetic stimulation system |
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Section 882.5805
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Transcranial magnetic stimulator for headache |
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Section 882.5808
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External functional neuromuscular stimulator |
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Section 882.5810
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Implanted cerebellar stimulator |
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Section 882.5820
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Implanted diaphragmatic/phrenic nerve stimulator |
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Section 882.5830
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Implanted intracerebral/subcortical stimulator for pain relief |
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Section 882.5840
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Implanted spinal cord stimulator for bladder evacuation |
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Section 882.5850
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Implanted neuromuscular stimulator |
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Section 882.5860
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Implanted peripheral nerve stimulator for pain relief |
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Section 882.5870
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Implanted spinal cord stimulator for pain relief |
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Section 882.5880
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Transcutaneous electrical nerve stimulator for pain relief |
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Section 882.5890
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Transcutaneous electrical nerve stimulator to treat headache |
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Section 882.5891
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Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites |
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Section 882.5894
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Preformed craniosynostosis strip |
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Section 882.5900
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Dura substitute |
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Section 882.5910
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Electroconvulsive therapy device |
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Section 882.5940
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Neurovascular embolization device |
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Section 882.5950
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Skull tongs for traction |
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Section 882.5960
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Cranial orthosis |
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Section 882.5970
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Human dura mater |
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Section 882.5975
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Scope |