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FDA 510(k) Application Details - K131965
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K131965
Device Name
Accelerator, Linear, Medical
Applicant
Elekta Limited
LINAC HOUSE, FLEMING WAY
CRAWLEY, WEST SUSSEX RH10 9RR GB
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Contact
ANDREW HEDGES
Other 510(k) Applications for this Contact
Regulation Number
892.5050
More FDA Info for this Regulation Number
Classification Product Code
IYE
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More FDA Info for this Product Code
Date Received
06/27/2013
Decision Date
09/25/2013
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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