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U.S. Department of Health and Human Services

Product Classification

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Device kit, chemical snake-bite
Regulation Description Chemical cold pack snakebite kit.
Definition Call for pmas to be filed by 12/26/96 per 61 fr 50708 on 9/27/96.
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodeKYQ
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type PMA
Regulation Number 880.5760
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible