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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 K181041
Device Name 7D Surgical System Cranial Application
Applicant
7D Surgical Inc.
60 Scarsdale Road, Unit 118
Toronto,  CA M3B 2R7
Applicant Contact Daniel Ziskind
Correspondent
7D Surgical Inc.
60 Scarsdale Road, Unit 118
Toronto,  CA M3B 2R7
Correspondent Contact Daniel Ziskind
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Code
OLO  
Date Received04/19/2018
Decision Date 08/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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