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FDA 510(k) Application Details - K121303
Device Classification Name
More FDA Info for this Device
510(K) Number
K121303
Device Name
MOBILE C-ARM
Applicant
CANON, INC.-MEDICAL EQUIPMENT GROUP
1201 RICHARDSON DRIVE
SUITE 280
RICHARDSON, TX 75080 US
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Contact
DIANE RUTHERFORD
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OXO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/01/2012
Decision Date
07/26/2012
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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