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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 Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
Submission Type PMA
Regulation Number 880.5760
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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