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510(k) K092083

EXTEND FRAME SYSTEM, MODEL 1009633 by Elekta Instrument AB — Product Code IWB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 22, 2009
Date Received
July 9, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Radiation Therapy, Radionuclide
Device Class
Class II
Regulation Number
892.5750
Review Panel
RA
Submission Type

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