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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 K132373
Device Name BIOMET ACCESS SYSTEM
Applicant
BIOMET SPINE (AKA EBI, LLC)
399 JEFFERSON ROAD
PARSIPPANY,  NJ  07054
Applicant Contact VIVIAN KELLY, MS, RAC
Correspondent
BIOMET SPINE (AKA EBI, LLC)
399 JEFFERSON ROAD
PARSIPPANY,  NJ  07054
Correspondent Contact VIVIAN KELLY, MS, RAC
Regulation Number874.1820
Classification Product Code
PDQ  
Date Received07/30/2013
Decision Date 03/27/2014
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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