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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name neurosurgical nerve locator
510(k) Number K201454
Device Name DSG Connect Technology
Applicant
SpineGuard, S.A.
10 Cours Louis Lumiere
Vincennes,  FR 94300
Applicant Contact Stephane Bette
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number874.1820
Classification Product Code
PDQ  
Subsequent Product Code
ETN  
Date Received06/01/2020
Decision Date 02/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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