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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 K051805
Device Name KENDALL SCD SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE THIGH), KENDALL SCD LEXPRES SLEEVES (EXTRA LARGE KNEE, EXTRA LARGE
Applicant
TYCO HEALTHCARE/KENDALL
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Applicant Contact BRIDGET GARDNER
Correspondent
TYCO HEALTHCARE/KENDALL
15 HAMPSHIRE STREET
MANSFIELD,  MA  02048
Correspondent Contact BRIDGET GARDNER
Regulation Number870.5800
Classification Product Code
JOW  
Date Received07/05/2005
Decision Date 10/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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