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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 K163620
Device Name Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves
Applicant
Covidien
15 Hampshire Stree
Mansfield,  MA  02048
Applicant Contact Nicole Genco
Correspondent
Covidien
15 Hampshire Stree
Mansfield,  MA  02048
Correspondent Contact Nicole Genco
Regulation Number870.5800
Classification Product Code
JOW  
Date Received12/22/2016
Decision Date 01/19/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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