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510(k) K211645

Epione by Quantum Surgical Sas — Product Code JAK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2022
Date Received
May 28, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Tomography, Computed
Device Class
Class II
Regulation Number
892.1750
Review Panel
RA
Submission Type

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