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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 K984204
Device Name SILVERLON DIRECT PRESSURE WOUND CLOSURE STRIP
Applicant
ARGENTUM INTERNATIONAL LLC.
PO BOX 429
LAKEMONT,  GA  30552
Applicant Contact A.BART FLICK
Correspondent
ARGENTUM INTERNATIONAL LLC.
PO BOX 429
LAKEMONT,  GA  30552
Correspondent Contact A.BART FLICK
Classification Product Code
FRO  
Date Received11/24/1998
Decision Date 03/19/2007
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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