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FDA 510(k) Application Details - K063030
Device Classification Name
Vehicle, Motorized 3-Wheeled
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510(K) Number
K063030
Device Name
Vehicle, Motorized 3-Wheeled
Applicant
COMFORT ORTHOPEDIC CO. LTD.
NO.58,FU-CHIUN ST.
HSIN-CHU CITY 30067 TW
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Contact
Ke-Min Jen
Other 510(k) Applications for this Contact
Regulation Number
890.3800
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Classification Product Code
INI
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More FDA Info for this Product Code
Date Received
10/03/2006
Decision Date
12/04/2006
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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