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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 K993976
Device Name PATHWAY VAGINAL EMG/STIM PERINEOMETER SENSOR, PATHWAY ANAL EMG/STIM PERINEOMETER SENSOR
Applicant
The Prometheus Group
2 Mallards Cove
Duxbury,  MA  02332
Applicant Contact RICHARD HORTON
Correspondent
The Prometheus Group
2 Mallards Cove
Duxbury,  MA  02332
Correspondent Contact RICHARD HORTON
Regulation Number876.5320
Classification Product Code
KPI  
Subsequent Product Code
HIR  
Date Received11/24/1999
Decision Date 02/22/2000
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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