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510(k) K160518

LEONI ORION System by Leoni Cia Cable System — Product Code JAI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 2016
Date Received
February 24, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Couch, Radiation Therapy, Powered
Device Class
Class II
Regulation Number
892.5770
Review Panel
RA
Submission Type

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