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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 K053590
Device Name SILVERLON CA (CALCIUM ALGINATE)
Applicant
ARGENTUM MEDICAL, LLC.
8 TOWER BRIDGE
161 WASHINGTON STREET
conshohocken,  PA  19428
Applicant Contact william a clemnti
Correspondent
ARGENTUM MEDICAL, LLC.
8 TOWER BRIDGE
161 WASHINGTON STREET
conshohocken,  PA  19428
Correspondent Contact william a clemnti
Classification Product Code
FRO  
Date Received12/23/2005
Decision Date 10/06/2006
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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