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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 K122817
Device Name SILVERLON ISLAND WOUND DRESSING
Applicant
ARGENTUM MEDICAL, LLC.
810 LANDMARK DRIVE
SUITE 126
glen burnie,  MD  21061
Applicant Contact walt brittle
Correspondent
ARGENTUM MEDICAL, LLC.
810 LANDMARK DRIVE
SUITE 126
glen burnie,  MD  21061
Correspondent Contact walt brittle
Classification Product Code
FRO  
Date Received09/14/2012
Decision Date 05/01/2014
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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