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FDA 510(k) Application Details - K092285
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K092285
Device Name
Accelerator, Linear, Medical
Applicant
BEST MEDICAL CANADA LTD.
413 MARCH ROAD
OTTAWA, ONTARIO K2K 034 CA
Other 510(k) Applications for this Company
Contact
MARY HERBERT
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
IYE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/29/2009
Decision Date
08/28/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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