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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 K254041
Device Name SkinSmart Antimicrobial HydroGel
Applicant
Magic Science Supply, LLC
5555 W 78th St. Suite M
Edina,  MN  55439
Applicant Contact Eoin Croke
Correspondent
Magic Science Supply, LLC
5555 W 78th St. Suite M
Edina,  MN  55439
Correspondent Contact Eoin Croke
Classification Product Code
FRO  
Date Received12/16/2025
Decision Date 09/11/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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