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510(k) K230015

OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver by Laurane Medical Sas — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2023
Date Received
January 3, 2023
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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