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FDA 510(k) Application Details - K002616
Device Classification Name
Vehicle, Motorized 3-Wheeled
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510(K) Number
K002616
Device Name
Vehicle, Motorized 3-Wheeled
Applicant
ELECTRIC MOBILITY CORP.
1 MOBILITY PLAZA
SEWELL, NJ 08080 US
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Contact
WALTER F ZARZYOKI
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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
08/22/2000
Decision Date
12/11/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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