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FDA 510(k) Application Details - K122726
Device Classification Name
System, X-Ray, Stationary
More FDA Info for this Device
510(K) Number
K122726
Device Name
System, X-Ray, Stationary
Applicant
COMMUNICATIONS & POWER INDUSTRIES CANADA, INC.
45 RIVER DRIVE
GEORGETOWN,ONTARIO L7G 2J4 CA
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Contact
NORM MORIKAWA
Other 510(k) Applications for this Contact
Regulation Number
892.1680
More FDA Info for this Regulation Number
Classification Product Code
KPR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/05/2012
Decision Date
02/15/2013
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
N
Expedited Review
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