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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 K112677
Device Name THE VENOUS ASSIST SYSTEM
Applicant
DAESUNG MAREF CO., LTD.
4568 WEST 1ST STREET
SUITE 104
LOS ANGELES,  CA  90004
Applicant Contact DANIEL NAM
Correspondent
DAESUNG MAREF CO., LTD.
4568 WEST 1ST STREET
SUITE 104
LOS ANGELES,  CA  90004
Correspondent Contact DANIEL NAM
Regulation Number870.5800
Classification Product Code
JOW  
Date Received09/14/2011
Decision Date 01/13/2012
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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