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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Neurological Stereotaxic Instrument
510(k) Number K230201
Device Name Disposable Pre-calibrated Brain Biopsy Needle 2.0
Applicant
PAJUNK GmbH Medizintechnologie
Karl-Hall-Str. 1
Geisingen,  DE 78187
Applicant Contact Christian Quass
Correspondent
PAJUNK GmbH Medizintechnologie
Karl-Hall-Str. 1
Geisingen,  DE 78187
Correspondent Contact Christian Quass
Regulation Number882.4560
Classification Product Code
HAW  
Date Received01/25/2023
Decision Date 02/22/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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