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FDA 510(k) Application Details - K063503
Device Classification Name
Injector, Contrast Medium, Automatic
More FDA Info for this Device
510(K) Number
K063503
Device Name
Injector, Contrast Medium, Automatic
Applicant
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS
2111 EAST GALBRAITH RD.
CINCINNATI, OH 45237 US
Other 510(k) Applications for this Company
Contact
DALE MOORE
Other 510(k) Applications for this Contact
Regulation Number
870.1650
More FDA Info for this Regulation Number
Classification Product Code
IZQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/20/2006
Decision Date
04/27/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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