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FDA 510(k) Application Details - K210109
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K210109
Device Name
Neurological Stereotaxic Instrument
Applicant
Eemagine Medical Imaging Solutions GmbH
Gubenerstr. 47, Fabrik D-10243
Berlin DE
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Contact
Maarten Van De Velde
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
HAW
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More FDA Info for this Product Code
Date Received
01/19/2021
Decision Date
04/08/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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