FDA 510(k) Application Details - K123076

Device Classification Name Wheelchair, Mechanical

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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
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Regulation Number 890.3850

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Classification Product Code IOR
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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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