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FDA 510(k) Application Details - K162862
Device Classification Name
Accelerator, Linear, Medical
More FDA Info for this Device
510(K) Number
K162862
Device Name
Accelerator, Linear, Medical
Applicant
Orfit Industries NV
9A VOSVELD
WIJNEGEM 2110 BE
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Contact
Raymond Kelly
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
10/12/2016
Decision Date
11/09/2016
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
Y
Expedited Review
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