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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 K041642
Device Name V.A.C. GRANUFOAM SILVER DRESSING
Applicant
Kinetic Concepts, Inc.
P.O. Box 659508
San Antonio,  TX  78265
Applicant Contact JUDITH HARBOUR
Correspondent
Kinetic Concepts, Inc.
P.O. Box 659508
San Antonio,  TX  78265
Correspondent Contact JUDITH HARBOUR
Regulation Number878.4780
Classification Product Code
OMP  
Date Received06/17/2004
Decision Date 01/25/2005
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
Predetermined Change
Control Plan Authorized		 No
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