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510(k) K200282

Orfit Aerial Couchtop by Orfit Industries NV — Product Code LHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2020
Date Received
February 4, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Radiation Therapy, Charged-Particle, Medical
Device Class
Class II
Regulation Number
892.5050
Review Panel
RA
Submission Type

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