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Title 21
PART 876 SUBPART F
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Volume 8
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Chapter I
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Subchapter H
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Part 876
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Subpart F
Subpart F - Therapeutic Devices
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
48 FR 53023, Nov. 23, 1983, unless otherwise noted.
21:8.0.1.1.25.6.1.1
SECTION 876.5010
876.5010 Biliary catheter and accessories.
21:8.0.1.1.25.6.1.2
SECTION 876.5011
876.5011 Metallic biliary stent system for benign strictures.
21:8.0.1.1.25.6.1.3
SECTION 876.5012
876.5012 Biliary stent, drain, and dilator accessories.
21:8.0.1.1.25.6.1.4
SECTION 876.5015
876.5015 Pancreatic drainage stent and delivery system.
21:8.0.1.1.25.6.1.5
SECTION 876.5020
876.5020 External penile rigidity devices.
21:8.0.1.1.25.6.1.6
SECTION 876.5025
876.5025 Vibrator for climax control of premature ejaculation.
21:8.0.1.1.25.6.1.7
SECTION 876.5030
876.5030 Continent ileostomy catheter.
21:8.0.1.1.25.6.1.8
SECTION 876.5090
876.5090 Suprapubic urological catheter and accessories.
21:8.0.1.1.25.6.1.9
SECTION 876.5100
876.5100 Suprapubic catheter accessories.
21:8.0.1.1.25.6.1.10
SECTION 876.5130
876.5130 Urological catheter and accessories.
21:8.0.1.1.25.6.1.11
SECTION 876.5140
876.5140 Urethral insert with pump for bladder drainage.
21:8.0.1.1.25.6.1.12
SECTION 876.5160
876.5160 Urological clamp.
21:8.0.1.1.25.6.1.13
SECTION 876.5210
876.5210 Enema kit.
21:8.0.1.1.25.6.1.14
SECTION 876.5220
876.5220 Colonic irrigation system.
21:8.0.1.1.25.6.1.15
SECTION 876.5250
876.5250 Urine collector and accessories.
21:8.0.1.1.25.6.1.16
SECTION 876.5270
876.5270 Implanted electrical urinary continence device.
21:8.0.1.1.25.6.1.17
SECTION 876.5280
876.5280 Implanted mechanical/hydraulic urinary continence device.
21:8.0.1.1.25.6.1.18
SECTION 876.5290
876.5290 Implanted mechanical/hydraulic urinary continence device surgical accessories.
21:8.0.1.1.25.6.1.19
SECTION 876.5310
876.5310 Nonimplanted, peripheral electrical continence device.
21:8.0.1.1.25.6.1.20
SECTION 876.5320
876.5320 Nonimplanted electrical continence device.
21:8.0.1.1.25.6.1.21
SECTION 876.5365
876.5365 Esophageal dilator.
21:8.0.1.1.25.6.1.22
SECTION 876.5450
876.5450 Rectal dilator.
21:8.0.1.1.25.6.1.23
SECTION 876.5470
876.5470 Ureteral dilator.
21:8.0.1.1.25.6.1.24
SECTION 876.5520
876.5520 Urethral dilator.
21:8.0.1.1.25.6.1.25
SECTION 876.5530
876.5530 Implantable transprostatic tissue retractor system.
21:8.0.1.1.25.6.1.26
SECTION 876.5540
876.5540 Blood access device and accessories.
21:8.0.1.1.25.6.1.27
SECTION 876.5550
876.5550 Prostatic artery embolization device.
21:8.0.1.1.25.6.1.28
SECTION 876.5600
876.5600 Sorbent regenerated dialysate delivery system for hemodialysis.
21:8.0.1.1.25.6.1.29
SECTION 876.5630
876.5630 Peritoneal dialysis system and accessories.
21:8.0.1.1.25.6.1.30
SECTION 876.5665
876.5665 Water purification system for hemodialysis.
21:8.0.1.1.25.6.1.31
SECTION 876.5820
876.5820 Hemodialysis system and accessories.
21:8.0.1.1.25.6.1.32
SECTION 876.5830
876.5830 Hemodialyzer with disposable insert (Kiil type).
21:8.0.1.1.25.6.1.33
SECTION 876.5860
876.5860 High permeability hemodialysis system.
21:8.0.1.1.25.6.1.34
SECTION 876.5870
876.5870 Sorbent hemoperfusion system.
21:8.0.1.1.25.6.1.35
SECTION 876.5880
876.5880 Isolated kidney perfusion and transport system and accessories.
21:8.0.1.1.25.6.1.36
SECTION 876.5885
876.5885 Tissue culture media for human ex vivo tissue and cell culture processing applications.
21:8.0.1.1.25.6.1.37
SECTION 876.5895
876.5895 Ostomy irrigator.
21:8.0.1.1.25.6.1.38
SECTION 876.5900
876.5900 Ostomy pouch and accessories.
21:8.0.1.1.25.6.1.39
SECTION 876.5920
876.5920 Protective garment for incontinence.
21:8.0.1.1.25.6.1.40
SECTION 876.5930
876.5930 Rectal control system.
21:8.0.1.1.25.6.1.41
SECTION 876.5955
876.5955 Peritoneo-venous shunt.
21:8.0.1.1.25.6.1.42
SECTION 876.5970
876.5970 Hernia support.
21:8.0.1.1.25.6.1.43
SECTION 876.5980
876.5980 Gastrointestinal tube and accessories.
21:8.0.1.1.25.6.1.44
SECTION 876.5981
876.5981 Oral removable palatal space occupying device for weight management and/or weight loss.
21:8.0.1.1.25.6.1.45
SECTION 876.5985
876.5985 Enzyme packed cartridge.
21:8.0.1.1.25.6.1.46
SECTION 876.5990
876.5990 Extracorporeal shock wave lithotripter.