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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K913611
Device Name COWBOY
Applicant
Kinetic Concepts, Inc.
4958 Stout Dr.
San Antonio,  TX  78219
Applicant Contact WILLIAM H QUIRK
Correspondent
Kinetic Concepts, Inc.
4958 Stout Dr.
San Antonio,  TX  78219
Correspondent Contact WILLIAM H QUIRK
Regulation Number870.5800
Classification Product Code
JOW  
Date Received08/14/1991
Decision Date 01/13/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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