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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K240722
Device Name Derma-R Cream (Derma-R Cream)
Applicant
Raya Pharmaceuticals, LLC
115 Kings Bay Rd.
Suite C
Kingsland,  GA  31548
Applicant Contact Parikh Ankur
Correspondent
Raya Pharmaceuticals, LLC
115 Kings Bay Rd.
Suite C
Kingsland,  GA  31548
Correspondent Contact Parikh Ankur
Classification Product Code
FRO  
Date Received03/18/2024
Decision Date 09/20/2024
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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