FDA 510(k) Application Details - K092155

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K092155
Device Name Vehicle, Motorized 3-Wheeled
Applicant HEARTWAY MEDICAL PRODUCTS CO., LTD.
NO.58, FU-CHIUN ST.
HSIN-CHU CITY 408 TW
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Contact Ke-Min Jen
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 07/16/2009
Decision Date 09/21/2009
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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