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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 K981311
Device Name COWBOY XV
Applicant
KCI NEW TECHNOLOGIES, INC.
8023 VANTAGE DR.
SAN ANTONIO,  TX  78230 -4726
Applicant Contact JUDITH HARBOUR
Correspondent
KCI NEW TECHNOLOGIES, INC.
8023 VANTAGE DR.
SAN ANTONIO,  TX  78230 -4726
Correspondent Contact JUDITH HARBOUR
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/10/1998
Decision Date 04/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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