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FDA 510(k) Application Details - K062645
Device Classification Name
Vehicle, Motorized 3-Wheeled
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510(K) Number
K062645
Device Name
Vehicle, Motorized 3-Wheeled
Applicant
SHANGHAI RUIKE SPORTS GOODS CO., LTD.
14F-2, NO.1, LANE 25
ZHUANGJING RD.
BANQIAO, TAIPEI COUNTY 220 TW
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Contact
JUNNATA CHANG
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
09/06/2006
Decision Date
12/19/2006
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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