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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, STE A-1
RENO,  NV  89502
Applicant Contact PATRICK PARKER
Correspondent
INTERTEK TESTING SERVICES
2307 EAST AURORA ROAD
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
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