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U.S. Department of Health and Human Services

Product Classification
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Device wound dressings containing topical analgesics
Definition A solid wound dressing containing topical analgesics is used to cover and protect a wound, to absorb exudate, to maintain appropriate moisture balance within the wound, and to reduce pain. A wound dressing formulated as a gel, cream or ointment containing topical analgesics is used to maintain appropriate moisture balance within the wound and to reduce pain.
Physical State Solid, or formulated as a gel, cream or ointment
Technical Method A wound dressing containing topical analgesics may additionally contain antimicrobials, other chemicals, and/or animal-derived materials.
Target Area External cutaneous (skin) wounds
Review Panel General & Plastic Surgery
Product CodeSEJ
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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