FDA 510(k) Application Details - K060068

Device Classification Name Vehicle, Motorized 3-Wheeled

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510(K) Number K060068
Device Name Vehicle, Motorized 3-Wheeled
Applicant LERADO CHINA LIMITED
CHONGDE RD., BEITUN DISTRICT
TAICHUNG 40653 TW
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Contact JEFF CHANG
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Regulation Number 890.3800

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Classification Product Code INI
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Date Received 01/09/2006
Decision Date 03/08/2006
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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