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510(k) K230201

Disposable Pre-calibrated Brain Biopsy Needle 2.0 by PAJUNK GmbH Medizintechnologie — Product Code HAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2023
Date Received
January 25, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurological Stereotaxic Instrument
Device Class
Class II
Regulation Number
882.4560
Review Panel
NE
Submission Type

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