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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 K021500
Device Name VACUUM ASSISTED CLOSURE
Applicant
Kinetic Concepts, Inc.
P.O. Box 659508
San Antonio,  TX  78265 -9508
Applicant Contact WILLIAM H QUIRK
Correspondent
Kinetic Concepts, Inc.
P.O. Box 659508
San Antonio,  TX  78265 -9508
Correspondent Contact WILLIAM H QUIRK
Regulation Number878.4780
Classification Product Code
OMP  
Date Received05/09/2002
Decision Date 12/20/2002
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 No
Predetermined Change
Control Plan Authorized		 No
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