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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 K152769
Device Name FREMAP ELECTRODE
Applicant
AD-TECH MEDICAL INSTRUMENT CORPORATION
1901 WILLIAM STREET
RACINE,  WI  53404
Applicant Contact LISA THEAMA
Correspondent
QUALITY & REGULATORY ASSOCIATES, LLC
800 LEVANGER LANE
STOUGHTON,  WI  53589
Correspondent Contact GARY J. SYRING
Regulation Number874.1820
Classification Product Code
ETN  
Date Received09/25/2015
Decision Date 05/06/2016
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
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