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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name equipment, traction, powered
510(k) Number K052453
Device Name TRACTION SYSTEM, DIGIT-TRAC 930
Applicant
EVER PROSPEROUS INSTRUMENT, INC.
NO. 58, FU-CHIUN STREET
HSIN CHU CITY,  TW 30067
Applicant Contact KE-MEN JEN
Correspondent
EVER PROSPEROUS INSTRUMENT, INC.
NO. 58, FU-CHIUN STREET
HSIN CHU CITY,  TW 30067
Correspondent Contact KE-MEN JEN
Regulation Number890.5900
Classification Product Code
ITH  
Date Received09/07/2005
Decision Date 01/13/2006
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
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