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FDA 510(k) Application Details - K981121
Device Classification Name
Vehicle, Motorized 3-Wheeled
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510(K) Number
K981121
Device Name
Vehicle, Motorized 3-Wheeled
Applicant
AMIGO MOBILITY INTL., INC.
6693 DIXIE HWY.
BRIDGEPORT, MI 48722 US
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Contact
ANDREA J LUPO
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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
03/27/1998
Decision Date
06/30/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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