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FDA 510(k) Application Details - K123076
Device Classification Name
Wheelchair, Mechanical
More FDA Info for this Device
510(K) Number
K123076
Device Name
Wheelchair, Mechanical
Applicant
HARMONY HILL INTERNATIONAL
RM. 1068, 10F, H BLDG. OF NKSP, NO.3-2
PARK ST., NANGANG DIST
TAIPEI 11503 TW
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Contact
TINA LAI
Other 510(k) Applications for this Contact
Regulation Number
890.3850
More FDA Info for this Regulation Number
Classification Product Code
IOR
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More FDA Info for this Product Code
Date Received
10/01/2012
Decision Date
08/09/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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