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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 EAST HOUSTON ST.
SAN ANTONIO,  TX  78219
Applicant Contact WILLIAM H QUIRK
Correspondent
KINETIC CONCEPTS, INC.
3440 EAST 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
Recalls CDRH Recalls
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