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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 K081480
Device Name KEGEL8 PELVIC EXERCISER, MODEL OPH 400
Applicant
Ne Services , Ltd.
4663 Kate Lane
Oxford,  OH  45056
Applicant Contact BRENT REIDER
Correspondent
Ne Services , Ltd.
4663 Kate Lane
Oxford,  OH  45056
Correspondent Contact BRENT REIDER
Regulation Number876.5320
Classification Product Code
KPI  
Date Received05/27/2008
Decision Date 09/12/2008
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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