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FDA 510(k) Application Details - K994107
Device Classification Name
Wheelchair, Powered
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510(K) Number
K994107
Device Name
Wheelchair, Powered
Applicant
AMYLIOR, INC.
6 ANTOINE-HENAULT
NOTE-DAME OF ILE PERROT,QUEBEC J7V 7M3 CA
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SYLVAIN DUGAS
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Regulation Number
890.3860
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Classification Product Code
ITI
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More FDA Info for this Product Code
Date Received
12/06/1999
Decision Date
01/13/2000
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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