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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
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