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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 K190163
Device Name ALARA Neuro Access Kit
Applicant
SurGenTec, LLC
7601 N Federal Highway #150A
Boca Raton,  FL  33487
Applicant Contact Travis Greenhalgh
Correspondent
Quality Solutions and Support, LLC
PO Box 8271
Holland,  MI  49422
Correspondent Contact Stephen Inglese
Regulation Number874.1820
Classification Product Code
PDQ  
Date Received01/31/2019
Decision Date 07/16/2019
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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