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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 K182662
Device Name NAV PAK Needle, NIM NAV PAK Needle
Applicant
Boston Endo Surgical Tech,
Division Of Lacey Manufacturing Co., Llc
1146 Barnum Ave.
Bridgeport,  CT  06610
Applicant Contact James Rogers
Correspondent
Boston Endo Surgical Tech,
Division Of Lacey Manufacturing Co., Llc
1146 Barnum Ave.
Bridgeport,  CT  06610
Correspondent Contact James Rogers
Regulation Number874.1820
Classification Product Code
PDQ  
Subsequent Product Code
OLO  
Date Received09/25/2018
Decision Date 04/10/2019
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
Predetermined Change
Control Plan Authorized		 No
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