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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve
510(k) Number K140400
Device Name ES2 NEUROMONITORING ACCESSORY INSTRUMENTS
Applicant
Stryker Corporation
2 Pearl Court
Allendale,  NJ  07401
Applicant Contact SORAYA KING
Correspondent
Stryker Corporation
2 Pearl Court
Allendale,  NJ  07401
Correspondent Contact SORAYA KING
Regulation Number874.1820
Classification Product Code
ETN  
Date Received02/18/2014
Decision Date 07/01/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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