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510(k) K233294

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM by Itp Innovative Tomography Products GmbH — Product Code KNW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2024
Date Received
September 29, 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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