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Electronic Code of Federal Regulations

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e-CFR Data is current as of April 15, 2014

TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER H—MEDICAL DEVICES

PART 878—GENERAL AND PLASTIC SURGERY DEVICES

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Subpart A—GENERAL PROVISIONS

§878.1
Scope.
§878.3
Effective dates of requirement for premarket approval.
§878.9
Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
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Subpart B—DIAGNOSTIC DEVICES

§878.1800
Speculum and accessories.
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Subpart C—[RESERVED]

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Subpart D—PROSTHETIC DEVICES

§878.3250
External facial fracture fixation appliance.
§878.3300
Surgical mesh.
§878.3500
Polytetrafluoroethylene with carbon fibers composite implant material.
§878.3530
Silicone inflatable breast prosthesis.
§878.3540
Silicone gel-filled breast prosthesis.
§878.3550
Chin prosthesis.
§878.3590
Ear prosthesis.
§878.3610
Esophageal prosthesis.
§878.3680
Nose prosthesis.
§878.3720
Tracheal prosthesis.
§878.3750
External prosthesis adhesive.
§878.3800
External aesthetic restoration prosthesis.
§878.3900
Inflatable extremity splint.
§878.3910
Noninflatable extremity splint.
§878.3925
Plastic surgery kit and accessories.
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Subpart E—SURGICAL DEVICES

§878.4010
Tissue adhesive.
§878.4011
Tissue adhesive with adjunct wound closure device for topical approximation of skin.
§878.4014
Nonresorbable gauze/sponge for external use.
§878.4015
Wound dressing with poly (diallyl dimethyl ammonium chloride) (pDADMAC) additive.
§878.4018
Hydrophilic wound dressing.
§878.4020
Occlusive wound dressing.
§878.4022
Hydrogel wound dressing and burn dressing.
§878.4025
Silicone sheeting.
§878.4040
Surgical apparel.
§878.4100
Organ bag.
§878.4160
Surgical camera and accessories.
§878.4200
Introduction/drainage catheter and accessories.
§878.4300
Implantable clip.
§878.4320
Removable skin clip.
§878.4340
Contact cooling system for aesthetic use.
§878.4350
Cryosurgical unit and accessories.
§878.4370
Surgical drape and drape accessories.
§878.4380
Drape adhesive.
§878.4400
Electrosurgical cutting and coagulation device and accessories.
§878.4410
Low energy ultrasound wound cleaner.
§878.4440
Eye pad.
§878.4450
Nonabsorbable gauze for internal use.
§878.4460
Surgeon's glove.
§878.4470
Surgeon's gloving cream.
§878.4480
Absorbable powder for lubricating a surgeon's glove.
§878.4490
Absorbable hemostatic agent and dressing.
§878.4493
Absorbable poly(glycolide/l-lactide) surgical suture.
§878.4494
Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
§878.4495
Stainless steel suture.
§878.4520
Polytetrafluoroethylene injectable.
§878.4580
Surgical lamp.
§878.4590
Focused ultrasound stimulator system for aesthetic use.
§878.4630
Ultraviolet lamp for dermatologic disorders.
§878.4635
Ultraviolet lamp for tanning.
§878.4660
Skin marker.
§878.4680
Nonpowered, single patient, portable suction apparatus.
§878.4683
Non-Powered suction apparatus device intended for negative pressure wound therapy.
§878.4700
Surgical microscope and accessories.
§878.4730
Surgical skin degreaser or adhesive tape solvent.
§878.4750
Implantable staple.
§878.4755
Absorbable Lung Biopsy Plug.
§878.4760
Removable skin staple.
§878.4780
Powered suction pump.
§878.4800
Manual surgical instrument for general use.
§878.4810
Laser surgical instrument for use in general and plastic surgery and in dermatology.
§878.4820
Surgical instrument motors and accessories/attachments.
§878.4830
Absorbable surgical gut suture.
§878.4840
Absorbable polydioxanone surgical suture.
§878.4930
Suture retention device.
§878.4950
Manual operating table and accessories and manual operating chair and accessories.
§878.4960
Operating tables and accessories and operating chairs and accessories.
§878.5000
Nonabsorbable poly(ethylene terephthalate) surgical suture.
§878.5010
Nonabsorbable polypropylene surgical suture.
§878.5020
Nonabsorbable polyamide surgical suture.
§878.5030
Natural nonabsorbable silk surgical suture.
§878.5035
Nonabsorbable expanded polytetrafluoroethylene surgical suture.
§878.5040
Suction lipoplasty system.
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Subpart F—THERAPEUTIC DEVICES

§878.5070
Air-handling apparatus for a surgical operating room.
§878.5350
Needle-type epilator.
§878.5360
Tweezer-type epilator.
§878.5400
Low level laser system for aesthetic use
§878.5650
Topical oxygen chamber for extremities.
§878.5900
Nonpneumatic tourniquet.
§878.5910
Pneumatic tourniquet.


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