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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 K113275
Device Name COMPRESSIBLE LIMB THERAPY SYSTEM
Applicant
Wonjin Mulsan Co., Ltd.
D-524 Migun Techno World 2
533-1 Yongsan-Dongyuseong-Gu
Daejeon,  KR KS
Applicant Contact EILEEN YANG
Correspondent
Wonjin Mulsan Co., Ltd.
D-524 Migun Techno World 2
533-1 Yongsan-Dongyuseong-Gu
Daejeon,  KR KS
Correspondent Contact EILEEN YANG
Regulation Number890.5650
Classification Product Code
IRP  
Date Received11/04/2011
Decision Date 02/27/2012
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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