FDA 510(k) Application Details - K031313

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K031313
Device Name Vehicle, Motorized 3-Wheeled
Applicant TMC TECHNOLOGY CORP.
NO. 58, FU-CHIUN ST.
HSIN-CHU CITY TW
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Contact JEN KE-MIN
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 04/24/2003
Decision Date 09/04/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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