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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 K221218
Device Name Silverlon Wound Contact, Burn Contact Dressings
Applicant
Argentum Medical, Inc.
2571 Kaneville Ct.
Geneva,  IL  60134
Applicant Contact Kathy Herzog
Correspondent
Argentum Medical, Inc.
2571 Kaneville Ct.
Geneva,  IL  60134
Correspondent Contact Kathy Herzog
Classification Product Code
FRO  
Date Received04/27/2022
Decision Date 10/26/2022
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT04238728
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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