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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 K141064
Device Name VESOFLOW PLUS DVT COMPRESSION DEVICE
Applicant
CAREMED SUPPLY, INC.
NO.45, MINSHENG RD.
DANSHUI TOWN
NEW TAIPEI CITY,  TW 251
Applicant Contact MICHAEL LEE
Correspondent
CAREMED SUPPLY, INC.
NO.45, MINSHENG RD.
DANSHUI TOWN
NEW TAIPEI CITY,  TW 251
Correspondent Contact MICHAEL LEE
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/24/2014
Decision Date 12/04/2014
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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