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U.S. Department of Health and Human Services

Product Classification
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Device wound dressings containing oxygen
Definition A wound dressing containing oxygen is intended to cover and protect a wound, to absorb exudate, and to maintain appropriate moisture balance within the wound.
Physical State Solid
Technical Method A wound dressing containing oxygen may additionally contain antimicrobials, other chemicals, and/or animal-derived materials.
Target Area External cutaneous (skin) wounds
Review Panel General & Plastic Surgery
Product CodeSIL
Premarket Review Plastic and Reconstructive Surgery Devices (DHT4B)
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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