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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 K251929
Device Name SilverCeuticals® Antimicrobial Wound Gel
Applicant
Silverceuticals, Inc.
1396 W 200 S, Suite 2c
Lindon,  UT  84042
Applicant Contact Cameron Moeller
Correspondent
Silverceuticals, Inc.
1396 W 200 S, Suite 2c
Lindon,  UT  84042
Correspondent Contact Cameron Moeller
Classification Product Code
FRO  
Date Received06/23/2025
Decision Date 06/24/2026
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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