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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bandage, liquid
510(k) Number K984207
Device Name SILVERLON DIRECT PRESSURE WOUND DRESSING
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
Regulation Number880.5090
Classification Product Code
KMF  
Date Received11/24/1998
Decision Date 03/19/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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