7D Surgical System Cranial Application

Neurological Stereotaxic Instrument

7D Surgical Inc.

The following data is part of a premarket notification filed by 7d Surgical Inc. with the FDA for 7d Surgical System Cranial Application.

Pre-market Notification Details

Device IDK181041
501k NumberK181041
Device Name:7D Surgical System Cranial Application
ClassificationNeurological Stereotaxic Instrument
Applicant 7D Surgical Inc. 60 Scarsdale Road, Unit 118 Toronto,  CA M3b 2r7
ContactDaniel Ziskind
CorrespondentDaniel Ziskind
7D Surgical Inc. 60 Scarsdale Road, Unit 118 Toronto,  CA M3b 2r7
Product CodeHAW  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
501k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-19
Decision Date2018-08-08
Summary:summary

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