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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 K141643
Device Name YARLAP
Applicant
International Trade Group, Inc.
4663 Katie Ln.
Suite O
Oxford,  OH  45056
Applicant Contact BRENT C REIDER
Correspondent
International Trade Group, Inc.
4663 Katie Ln.
Suite O
Oxford,  OH  45056
Correspondent Contact BRENT C REIDER
Regulation Number876.5320
Classification Product Code
KPI  
Date Received06/19/2014
Decision Date 04/24/2015
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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