FDA 510(k) Application Details - K130017

Device Classification Name Wheelchair, Mechanical

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510(K) Number K130017
Device Name Wheelchair, Mechanical
Applicant VALENTINE INTL. LTD.
8TH FL., NO. 149, SEC. 2,
TA TUNG RD. HSICHIH DISTRICT
NEW TAIPEI CITY 221 TW
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Contact JEN KE-MIN
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Regulation Number 890.3850

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Classification Product Code IOR
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Date Received 01/02/2013
Decision Date 05/28/2014
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 N
Expedited Review



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