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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Negative Pressure Wound Therapy Powered Suction Pump
510(k) Number K141033
Device Name SILVERLON ANTIMICROBIAL WOUND CONTACT NEGATIVE PRESSURE DRESSINGS, SILVERLON EASY AG ANTIMICROBIAL WOUND CONTACT NEGATIV
Applicant
ARGENTUM MEDICAL, LLC
2571 KANEVILLE COURT
GENEVA,  IL  60134
Applicant Contact C. RICHARD FOSTER
Correspondent
ARGENTUM MEDICAL, LLC
2571 KANEVILLE COURT
GENEVA,  IL  60134
Correspondent Contact C. RICHARD FOSTER
Regulation Number878.4780
Classification Product Code
OMP  
Date Received04/22/2014
Decision Date 09/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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