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510(k) K240664

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) by SurGenTec, LLC — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2024
Date Received
March 8, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Biopsy
Device Class
Class II
Regulation Number
876.1075
Review Panel
SU
Submission Type

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