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FDA 510(k) Application Details - K051028
Device Classification Name
Vehicle, Motorized 3-Wheeled
More FDA Info for this Device
510(K) Number
K051028
Device Name
Vehicle, Motorized 3-Wheeled
Applicant
AFIKIM ELECTRIC VEHICLES
KIBBUTZ AFIKIM 15148 IL
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Contact
AVNER FISHBEIN
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
04/22/2005
Decision Date
01/27/2006
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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