CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 880—GENERAL HOSPITAL AND PERSONAL USE DEVICES > SUBPART F—General Hospital and Personal Use Therapeutic Devices (§880.5025 to §880.5970) > 880.5760—Chemical cold pack snakebite kit.

880.5760—Chemical cold pack snakebite kit.

(a) Identification. A chemical cold pack snakebit kit is a device consisting of a chemical cold pack and tourniquet used for first-aid treatment of snakebites.
(b) Classification. Class III (premarket approval).
(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any chemical cold pack snakebite kit that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a chemical cold pack snakebite kit that was in commercial distribution before May 28, 1976. Any other chemical cold pack snakebite kit shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Code of Federal Regulations

[45 FR 69682-69737, Oct. 21, 1980, as amended at 52 FR 17739, May 11, 1987; 61 FR 50708, Sept. 27, 1996]