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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 K132360
Device Name KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER
Applicant
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact ASHLEY GONCALO
Correspondent
Covidien
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact ASHLEY GONCALO
Regulation Number870.5800
Classification Product Code
JOW  
Date Received07/30/2013
Decision Date 08/27/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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