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FDA 510(k) Application Details - K071282
Device Classification Name
Vehicle, Motorized 3-Wheeled
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510(K) Number
K071282
Device Name
Vehicle, Motorized 3-Wheeled
Applicant
DALTON MEDICAL CORP.
1103 VENTURE CT.
CARROLLTON, TX 75006 US
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Contact
WILL RIDGWAY
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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
05/07/2007
Decision Date
07/27/2007
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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