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510(k) K151207

Proton Immobilization Solution by Orfit Industries NV — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2015
Date Received
May 6, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accelerator, Linear, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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