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FDA 510(k) Application Details - K112074
Device Classification Name
Equipment, Traction, Powered
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
890.5900
More FDA Info for this Regulation Number
Classification Product Code
ITH
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More FDA Info for this Product Code
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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