FDA 510(k) Application Details - K052453

Device Classification Name Equipment, Traction, Powered

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510(K) Number K052453
Device Name Equipment, Traction, Powered
Applicant EVER PROSPEROUS INSTRUMENT, INC.
NO. 58, FU-CHIUN STREET
HSIN CHU CITY 30067 TW
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Contact KE-MEN JEN
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Regulation Number 890.5900

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Classification Product Code ITH
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Date Received 09/07/2005
Decision Date 01/13/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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