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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 K100306
Device Name KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES
Applicant
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact MIA PROLI
Correspondent
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact MIA PROLI
Regulation Number870.5800
Classification Product Code
JOW  
Date Received02/03/2010
Decision Date 05/04/2010
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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