FDA 510(k) Application Details - K140204

Device Classification Name Wheelchair, Powered

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510(K) Number K140204
Device Name Wheelchair, Powered
Applicant YAMAHA MOTOR CO., LTD.
882 SOUDE, NAKA-KU
HAMAMATSU, SHIZUOKA 435-0054 JP
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Contact MASANORI YONEMITSU
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Regulation Number 890.3860

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Classification Product Code ITI
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Date Received 01/27/2014
Decision Date 08/28/2014
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 Y
Expedited Review



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