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FDA 510(k) Application Details - K060697
Device Classification Name
Vehicle, Motorized 3-Wheeled
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510(K) Number
K060697
Device Name
Vehicle, Motorized 3-Wheeled
Applicant
MEGA MOTION, INC.
957 WOOD ST.
OLD FORGE, PA 18518 US
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Contact
MARK CALOMINO
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
03/16/2006
Decision Date
04/11/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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