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FDA 510(k) Application Details - K031333
Device Classification Name
System, X-Ray, Angiographic
More FDA Info for this Device
510(K) Number
K031333
Device Name
System, X-Ray, Angiographic
Applicant
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
VEENPLUIS 4-6
P.O. BOX 10000
5680 DA BEST 5680 NL
Other 510(k) Applications for this Company
Contact
LYNN HARMER
Other 510(k) Applications for this Contact
Regulation Number
892.1600
More FDA Info for this Regulation Number
Classification Product Code
IZI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/28/2003
Decision Date
05/13/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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