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510(k) K111332

CLARITY OBP SYSTEM by Elekta , Ltd. — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2012
Date Received
May 11, 2011
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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