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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 K123390
Device Name PEDIGUARD NERVE DETECTOR SYSTEM
Applicant
Spineguard S.A.
555 13th St. NW
Washington,  DC  20004
Applicant Contact JOHN J SMITH, M.D. J.D.
Correspondent
Spineguard S.A.
555 13th St. NW
Washington,  DC  20004
Correspondent Contact JOHN J SMITH, M.D. J.D.
Regulation Number874.1820
Classification Product Code
PDQ  
Subsequent Product Code
ETN  
Date Received11/02/2012
Decision Date 08/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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