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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 K101702
Device Name MIDWEST REPROCESSING CENTER REPROCESSED VENODYNE SLEEVES/FOOT CUFFS
Applicant
Midwest Reprocessing Center, LLC
434 Industrial Lane
Birmingham,  AL  35211
Applicant Contact JEROME JAMES
Correspondent
Midwest Reprocessing Center, LLC
434 Industrial Lane
Birmingham,  AL  35211
Correspondent Contact JEROME JAMES
Regulation Number870.5800
Classification Product Code
JOW  
Date Received06/17/2010
Decision Date 08/27/2010
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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