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FDA 510(k) Application Details - K113577
Device Classification Name
Wheelchair, Powered
More FDA Info for this Device
510(K) Number
K113577
Device Name
Wheelchair, Powered
Applicant
MERITS HEALTH PRODUCTS CO., LTD.
NO.18 JINGKE RD.
NANTUN DIST
TAICHUNG 40852 TW
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Contact
STEVE CHAO
Other 510(k) Applications for this Contact
Regulation Number
890.3860
More FDA Info for this Regulation Number
Classification Product Code
ITI
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More FDA Info for this Product Code
Date Received
12/05/2011
Decision Date
05/08/2012
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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