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FDA 510(k) Application Details - K063090
Device Classification Name
Injector, Contrast Medium, Automatic
More FDA Info for this Device
510(K) Number
K063090
Device Name
Injector, Contrast Medium, Automatic
Applicant
MEDRAD, INC.
ONE MEDRAD DR.
INDIANOLA, PA 15051 US
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Contact
TROY A JACK
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
10/10/2006
Decision Date
03/27/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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