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U.S. Department of Health and Human Services

Product Classification
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Device hemostatic wound dressing without thrombin or other biologics
Definition To temporarily control bleeding and cover external wounds.
Physical State Commonly a solid sheet, powder form, or semi-solid form.
Technical Method Predominantly physical action, such as absorption of moisture from blood and thereby clumping the platelets, and by providing a tamponade effect.
Target Area Topical wounds
Review Panel General & Plastic Surgery
Product CodeQSY
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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