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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 K180570
Device Name Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)
Applicant
Argentum Medical, LLC
2571 Kaneville CT
geneva,  IL  60134
Applicant Contact paul boentges
Correspondent
Argentum Medical, LLC
2571 Kaneville CT
geneva,  IL  60134
Correspondent Contact kartik patel
Classification Product Code
FRO  
Date Received03/05/2018
Decision Date 01/14/2019
Decision substantially equivalent (SESE)
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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