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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Non-Implantable, For Incontinence
510(k) Number K160773
Device Name Yarlap II
Applicant
INTERNATIONAL TRADE GROUP, INC.
4663 KATIE LANE
OXFORD,  OH  45056
Applicant Contact BRENT C. REIDER
Correspondent
INTERNATIONAL TRADE GROUP, INC.
4663 KATIE LANE
OXFORD,  OH  45056
Correspondent Contact BRENT C. REIDER
Regulation Number876.5320
Classification Product Code
KPI  
Subsequent Product Code
HCC  
Date Received03/21/2016
Decision Date 05/04/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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