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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 K890938
Device Name KENDALL SCD THERAPEUTIC SYSTEM
Applicant
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Applicant Contact JANE R ARNOLD
Correspondent
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
15 HAMPSHIRE ST.
MANSFIELD,  MA  02048
Correspondent Contact JANE R ARNOLD
Regulation Number870.5800
Classification Product Code
JOW  
Date Received02/24/1989
Decision Date 05/19/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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