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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K112441
Device Name COMPRESSIBLE LIMB AND CIRCULATION THERAPY SYSTEM
Applicant
Daesung Maref Co., Ltd.
4568 W. 1st St. Suite 104
Los Angeles,  CA  90004
Applicant Contact DANIEL NAM
Correspondent
Daesung Maref Co., Ltd.
4568 W. 1st St. Suite 104
Los Angeles,  CA  90004
Correspondent Contact DANIEL NAM
Regulation Number890.5650
Classification Product Code
IRP  
Date Received08/24/2011
Decision Date 01/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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