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Section 880.1
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Effective dates of requirement for premarket approval |
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Section 880.3
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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 880.9
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Liquid crystal forehead temperature strip |
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Section 880.2200
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Bed-patient monitor |
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Section 880.2400
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Electronic monitor for gravity flow infusion systems |
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Section 880.2420
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Electrically powered spinal fluid pressure monitor |
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Section 880.2460
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Spinal fluid manometer |
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Section 880.2500
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Stand-on patient scale |
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Section 880.2700
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Patient scale |
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Section 880.2720
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Surgical sponge scale |
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Section 880.2740
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Sterilization process indicator |
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Section 880.2800
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Clinical color change thermometer |
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Section 880.2900
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Clinical electronic thermometer |
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Section 880.2910
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Clinical mercury thermometer |
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Section 880.2920
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Apgar timer |
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Section 880.2930
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I |
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Section 880.5025
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Medical recirculating air cleaner |
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Section 880.5045
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Elastic bandage |
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Section 880.5075
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Liquid bandage |
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Section 880.5090
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AC-powered adjustable hospital bed |
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Section 880.5100
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Hydraulic adjustable hospital bed |
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Section 880.5110
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Manual adjustable hospital bed |
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Section 880.5120
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Infant radiant warmer |
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Section 880.5130
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Pediatric hospital bed |
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Section 880.5140
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Nonpowered flotation therapy mattress |
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Section 880.5150
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Therapeutic medical binder |
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Section 880.5160
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Burn sheet |
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Section 880.5180
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Intravascular catheter |
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Section 880.5200
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Intravascular catheter securement device |
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Section 880.5210
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Medical adhesive tape and adhesive bandage |
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Section 880.5240
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Neonatal eye pad |
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Section 880.5270
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Medical absorbent fiber |
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Section 880.5300
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Neonatal incubator |
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Section 880.5400
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Neonatal transport incubator |
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Section 880.5410
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Pressure infusor for an I |
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Section 880.5420
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Nonelectrically powered fluid injector |
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Section 880.5430
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Intravascular administration set |
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Section 880.5440
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Intravascular administration set, automated air removal system |
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Section 880.5445
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Patient care reverse isolation chamber |
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Section 880.5450
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Jet lavage |
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Section 880.5475
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AC-powered patient lift |
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Section 880.5500
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Non-AC-powered patient lift |
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Section 880.5510
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Alternating pressure air flotation mattress |
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Section 880.5550
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Temperature regulated water mattress |
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Section 880.5560
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Hypodermic single lumen needle |
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Section 880.5570
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Acupuncture needle |
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Section 880.5580
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Nipple shield |
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Section 880.5630
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Lamb feeding nipple |
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Section 880.5640
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Pediatric position holder |
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Section 880.5680
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Neonatal phototherapy unit |
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Section 880.5700
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Infusion pump |
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Section 880.5725
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Suction snakebite kit |
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Section 880.5740
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Chemical cold pack snakebite kit |
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Section 880.5760
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Medical support stocking |
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Section 880.5780
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Therapeutic scrotal support |
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Section 880.5820
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Piston syringe |
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Section 880.5860
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Umbilical occlusion device |
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Section 880.5950
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Lice removal kit |
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Section 880.5960
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Subcutaneous, implanted, intravascular infusion port and catheter |
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Section 880.5965
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Percutaneous, implanted, long-term intravascular catheter |
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Section 880.5970
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Absorbent tipped applicator |
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Section 880.6025
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Ice bag |
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Section 880.6050
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Medical disposable bedding |
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Section 880.6060
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Bed board |
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Section 880.6070
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Cardiopulmonary resuscitation board |
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Section 880.6080
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Hot/cold water bottle |
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Section 880.6085
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Ethylene oxide gas aerator cabinet |
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Section 880.6100
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Medical chair and table |
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Section 880.6140
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Ultrasonic cleaner for medical instruments |
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Section 880.6150
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Cast cover |
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Section 880.6185
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Mattress cover for medical purposes |
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Section 880.6190
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Ring cutter |
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Section 880.6200
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Tongue depressor |
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Section 880.6230
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Patient examination glove |
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Section 880.6250
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Filtering facepiece respirator for use by the general public in public health medical emergencies |
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Section 880.6260
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Examination gown |
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Section 880.6265
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Medical insole |
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Section 880.6280
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Implantable radiofrequency transponder system for patient identification and health information |
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Section 880.6300
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Ingestible event marker |
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Section 880.6305
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Medical device data system |
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Section 880.6310
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Remote Medication Management System |
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Section 880.6315
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AC-powered medical examination light |
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Section 880.6320
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Battery-powered medical examination light |
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Section 880.6350
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Patient lubricant |
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Section 880.6375
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Liquid medication dispenser |
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Section 880.6430
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Skin pressure protectors |
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Section 880.6450
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Medical ultraviolet air purifier |
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Section 880.6500
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Medical ultraviolet water purifier |
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Section 880.6710
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Body waste receptacle |
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Section 880.6730
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Vacuum-powered body fluid suction apparatus |
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Section 880.6740
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Protective restraint |
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Section 880.6760
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Powered patient transfer device |
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Section 880.6775
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Manual patient transfer device |
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Section 880.6785
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Washers for body waste receptacles |
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Section 880.6800
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Medical disposable scissors |
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Section 880.6820
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Sterilization wrap |
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Section 880.6850
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Ethylene oxide gas sterilizer |
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Section 880.6860
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Dry-heat sterilizer |
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Section 880.6870
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Steam sterilizer |
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Section 880.6880
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Liquid chemical sterilants/high level disinfectants |
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Section 880.6885
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General purpose disinfectants |
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Section 880.6890
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Hand-carried stretcher |
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Section 880.6900
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Wheeled stretcher |
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Section 880.6910
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Syringe needle introducer |
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Section 880.6920
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Irrigating syringe |
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Section 880.6960
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Liquid crystal vein locator |
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Section 880.6970
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Vein stabilizer |
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Section 880.6980
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Infusion stand |
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Section 880.6990
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Medical washer |
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Section 880.6991
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Medical washer-disinfector |
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Section 880.6992
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Scope |