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510(k) K213942

Esteya by Nucletron B.V. — Product Code JAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2022
Date Received
December 17, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Therapeutic, X-Ray
Device Class
Class II
Regulation Number
892.5900
Review Panel
RA
Submission Type

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