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U.S. Department of Health and Human Services

Product Classification
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Device wound dressings with hydrocortisone
Definition A wound dressing containing hydrocortisone is used to maintain appropriate moisture balance within the wound
Physical State Gel, cream or ointment
Technical Method The wound dressings are made of synthetic or naturally derived materials
Target Area External cutaneous (skin) wounds
Review Panel General & Plastic Surgery
Product CodeSEK
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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