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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 K191422
Device Name Neural Navigator
Applicant
Soterix Medical, Inc.
237 W 35 ST, 1401
New York,  NY  10001
Applicant Contact Abhishek Datta
Correspondent
Soterix Medical, Inc.
237 W 35 ST, 1401
New York,  NY  10001
Correspondent Contact Abhishek Datta
Regulation Number882.4560
Classification Product Code
HAW  
Subsequent Product Codes
GWF   IKN   OBP  
Date Received05/29/2019
Decision Date 04/06/2020
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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