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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 K872791
Device Name POREX NERVE LOCATOR
Applicant
Porex Medical
500 Bohannon Rd.
Fairburn,  GA  30213
Applicant Contact MERCER, PHD
Correspondent
Porex Medical
500 Bohannon Rd.
Fairburn,  GA  30213
Correspondent Contact MERCER, PHD
Regulation Number874.1820
Classification Product Code
ETN  
Date Received07/14/1987
Decision Date 10/20/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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