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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 K143001
Device Name SILVERLON ISLAND WOUND DRESSING, SILVERLON WOUND PAD DRESSING
Applicant
Argentum Medical
2571 Kaneville Court
Geneva,  IL  60134
Applicant Contact C. Richard Foster
Correspondent
Argentum Medical
2571 Kaneville Court
Geneva,  IL  60134
Correspondent Contact C Richard Foster
Classification Product Code
FRO  
Date Received10/17/2014
Decision Date 11/07/2014
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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