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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 K944567
Device Name COWBOY X
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 Number870.5800
Classification Product Code
JOW  
Date Received09/19/1994
Decision Date 06/21/1995
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
Recalls CDRH Recalls
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