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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 K971548
Device Name AMBUVAC
Applicant
Kinetic Concepts, Inc.
3440 E. Houston St.
San Antonio,  TX  78219
Applicant Contact WILLIAM H QUIRK
Correspondent
Kinetic Concepts, Inc.
3440 E. Houston St.
San Antonio,  TX  78219
Correspondent Contact WILLIAM H QUIRK
Regulation Number878.4780
Classification Product Code
OMP  
Date Received04/28/1997
Decision Date 05/22/1997
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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