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FDA 510(k) Application Details - K170058
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K170058
Device Name
Accelerator, Linear, Medical
Applicant
Cablon Medical B.V.
Klepelhoek 11
Leusden 3833 GZ NL
Other 510(k) Applications for this Company
Contact
Jurjen Weistra
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
01/06/2017
Decision Date
03/03/2017
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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