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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 K192945
Device Name 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application
Applicant
7D Surgical Inc.
60 Scarsdale Road, Unit 118
Toronto,  CA M3B 2R7
Applicant Contact Daniel Zisind
Correspondent
7D Surgical Inc.
60 Scarsdale Road, Unit 118
Toronto,  CA M3B 2R7
Correspondent Contact Daniel Zisind
Regulation Number882.4560
Classification Product Code
HAW  
Date Received10/18/2019
Decision Date 11/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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