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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 K962009
Device Name UROSTYM
Applicant
Laborie Medical Technologies, Ltd.
7 Green Tree Dr.
South Burlington,  VT  05403
Applicant Contact MIKE BARRE
Correspondent
Laborie Medical Technologies, Ltd.
7 Green Tree Dr.
South Burlington,  VT  05403
Correspondent Contact MIKE BARRE
Regulation Number876.5320
Classification Product Code
KPI  
Subsequent Product Code
HIR  
Date Received05/22/1996
Decision Date 05/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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