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Section 876.1
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Effective dates of requirement for premarket approval |
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Section 876.3
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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 876.9
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Gastroenterology-urology biopsy instrument |
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Section 876.1075
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Ingestible telemetric gastrointestinal capsule imaging system |
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Section 876.1300
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Colon capsule endoscopy system |
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Section 876.1330
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Stomach pH electrode |
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Section 876.1400
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Endoscope and accessories |
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Section 876.1500
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Urodynamics measurement system |
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Section 876.1620
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Gastrointestinal motility monitoring system |
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Section 876.1725
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Electrogastrography system |
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Section 876.1735
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Urine flow or volume measuring system |
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Section 876.1800
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Enuresis alarm |
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Section 876.2040
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Penile inflatable implant |
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Section 876.3350
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Penile rigidity implant |
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Section 876.3630
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Testicular prosthesis |
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Section 876.3750
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Fiberoptic light ureteral catheter |
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Section 876.4020
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Colostomy rod |
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Section 876.4270
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Endoscopic electrosurgical unit and accessories |
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Section 876.4300
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Gastroenterology-urology evacuator |
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Section 876.4370
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Hemorrhoidal ligator |
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Section 876.4400
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Electrohydraulic lithotriptor |
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Section 876.4480
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Mechanical lithotriptor |
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Section 876.4500
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Gastroenterology-urology fiberoptic retractor |
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Section 876.4530
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Ribdam |
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Section 876.4560
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Interlocking urethral sound |
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Section 876.4590
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Ureteral stent |
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Section 876.4620
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Water jet renal stone dislodger system |
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Section 876.4650
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Ureteral stone dislodger |
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Section 876.4680
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Manual gastroenterology-urology surgical instrument and accessories |
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Section 876.4730
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Urethrotome |
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Section 876.4770
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Urological table and accessories |
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Section 876.4890
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Biliary catheter and accessories |
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Section 876.5010
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Pancreatic drainage stent and delivery system |
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Section 876.5015
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External penile rigidity devices |
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Section 876.5020
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Continent ileostomy catheter |
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Section 876.5030
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Suprapubic urological catheter and accessories |
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Section 876.5090
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Urological catheter and accessories |
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Section 876.5130
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Urological clamp for males |
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Section 876.5160
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Enema kit |
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Section 876.5210
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Colonic irrigation system |
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Section 876.5220
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Urine collector and accessories |
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Section 876.5250
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Implanted electrical urinary continence device |
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Section 876.5270
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Implanted mechanical/hydraulic urinary continence device |
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Section 876.5280
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Nonimplanted, peripheral electrical continence device |
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Section 876.5310
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Nonimplanted electrical continence device |
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Section 876.5320
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Esophageal dilator |
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Section 876.5365
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Rectal dilator |
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Section 876.5450
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Ureteral dilator |
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Section 876.5470
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Urethral dilator |
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Section 876.5520
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Implantable transprostatic tissue retractor system |
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Section 876.5530
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Blood access device and accessories |
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Section 876.5540
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Sorbent regenerated dialysate delivery system for hemodialysis |
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Section 876.5600
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Peritoneal dialysis system and accessories |
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Section 876.5630
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Water purification system for hemodialysis |
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Section 876.5665
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Hemodialysis system and accessories |
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Section 876.5820
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Hemodialyzer with disposable insert (Kiil type) |
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Section 876.5830
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High permeability hemodialysis system |
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Section 876.5860
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Sorbent hemoperfusion system |
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Section 876.5870
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Isolated kidney perfusion and transport system and accessories |
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Section 876.5880
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Tissue culture media for human ex vivo tissue and cell culture processing applications |
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Section 876.5885
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Ostomy irrigator |
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Section 876.5895
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Ostomy pouch and accessories |
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Section 876.5900
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Protective garment for incontinence |
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Section 876.5920
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Peritoneo-venous shunt |
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Section 876.5955
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Hernia support |
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Section 876.5970
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Gastrointestinal tube and accessories |
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Section 876.5980
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Extracorporeal shock wave lithotripter |
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Section 876.5990
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Scope |