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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 K891007
Device Name NONIMPLANTED ELECTRICAL CONTINENCE DEVICE
Applicant
Tridak Division of Indicon, Inc.
20 Commerce St. Unit 2
P.O. Box 907
Williston,  VT  05495
Applicant Contact CLAUDE REGNIER
Correspondent
Tridak Division of Indicon, Inc.
20 Commerce St. Unit 2
P.O. Box 907
Williston,  VT  05495
Correspondent Contact CLAUDE REGNIER
Regulation Number876.5320
Classification Product Code
KPI  
Date Received02/27/1989
Decision Date 06/07/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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