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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
Predetermined Change
Control Plan Authorized		 No
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