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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 K241225
Device Name Silverlon® Wound Contact, Burn Contact Dressing
Applicant
Argentum Medical LLC
2571 Kaneville Ct
Geneva,  IL  60134
Applicant Contact James Fitzgerald
Correspondent
DuVal & Associates, P.A.
1820 Medical Arts Building
825 Nicollet Mall
Minneapolis,  MN  55402
Correspondent Contact Kathy Herzog
Classification Product Code
FRO  
Date Received05/02/2024
Decision Date 07/31/2024
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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