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510(k) K171734

HP PRO Positioning Device by Orfit Industries NV — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2017
Date Received
June 12, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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