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FDA 510(k) Application Details - K192945
Device Classification Name
Neurological Stereotaxic Instrument
More FDA Info for this Device
510(K) Number
K192945
Device Name
Neurological Stereotaxic Instrument
Applicant
7D Surgical Inc.
60 Scarsdale Road, Unit 118
Toronto M3B 2R7 CA
Other 510(k) Applications for this Company
Contact
Daniel Zisind
Other 510(k) Applications for this Contact
Regulation Number
882.4560
More FDA Info for this Regulation Number
Classification Product Code
HAW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/18/2019
Decision Date
11/27/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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