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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 K190343
Device Name Silverlon Wound Contact, Burn Contact Dressings
Applicant
Argentum Medical, LLC
2571 Kaneville CT
Geneva,  IL  60134
Applicant Contact Aftab Ahmad
Correspondent
Argentum Medical, LLC
2571 Kaneville CT
Geneva,  IL  60134
Correspondent Contact Aftab Ahmad
Classification Product Code
FRO  
Date Received02/14/2019
Decision Date 07/18/2019
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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