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U.S. Department of Health and Human Services

Product Classification
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Device absorbable synthetic wound dressing
Definition Intended as a physical barrier to cover the wound and provide a moist wound environment. Intended to be left on wounds after topical application.
Physical State Commonly a solid sheet
Technical Method Physical barrier to cover the wound and provide a moist wound environment.
Target Area Topical wounds 
Review Panel General & Plastic Surgery
Product CodeQSZ
Premarket Review Office of Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic and Reconstructive Surgery Devices (DHT4B)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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