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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 K110977
Device Name VESOFLOW
Applicant
Caremed Supply, Inc.
5905 Fawn Lane
Cleveland,  OH  44141
Applicant Contact EDWARD A KROLL
Correspondent
Caremed Supply, Inc.
5905 Fawn Lane
Cleveland,  OH  44141
Correspondent Contact EDWARD A KROLL
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/07/2011
Decision Date 08/25/2011
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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