FDA 510(k) Application Details - K112074

Device Classification Name Equipment, Traction, Powered

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510(K) Number K112074
Device Name Equipment, Traction, Powered
Applicant EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
845 ARONSON LAKE COURT
ROSWELL, GA 30075 US
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Contact JAY MANSOUR
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Regulation Number 890.5900

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Classification Product Code ITH
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Date Received 07/20/2011
Decision Date 02/01/2012
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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