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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 K093600
Device Name OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM
Applicant
Accelerated Care Plus
4850 Joule St., Suite A-1
Reno,  NV  89502
Applicant Contact PATRICK PARKER
Correspondent
Intertek Testing Services
2307 E. Aurora Rd.
Unit B7
Twinsburg,  OH  44087
Correspondent Contact JAY Y KOGOMA
Regulation Number876.5320
Classification Product Code
KPI  
Date Received11/20/2009
Decision Date 12/04/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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