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U.S. Department of Health and Human Services

Product Classification

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Device bandage, liquid
Regulation Description Liquid bandage.
Regulation Medical Specialty General Hospital
Review Panel General & Plastic Surgery
Product CodeKMF
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Plastic and Reconstructive Surgery Devices (DHT4B)
Submission Type 510(k)
Regulation Number 880.5090
Device Class 1
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
Accredited Persons
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