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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 K040649
Device Name KENDALL SCD EXPRESS KAMBIA THIGH LENGTH TEARAWAY SLEEVE
Applicant
Tyco Healthcare
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact GAIL CHRISTIE
Correspondent
Tyco Healthcare
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact GAIL CHRISTIE
Regulation Number870.5800
Classification Product Code
JOW  
Date Received03/11/2004
Decision Date 07/15/2004
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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