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510(k) K213439

FlexBoardTM, EagleBoardTM, BreastBoard SXTM by Macromedics BV — Product Code IYE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 2022
Date Received
October 25, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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