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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 K993721
Device Name UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES
Applicant
Laborie Medical Tech Corp.
310 Hurricane Ln. #2
Williston,  VT  05495
Applicant Contact DALE COLEMAN
Correspondent
Laborie Medical Tech Corp.
310 Hurricane Ln. #2
Williston,  VT  05495
Correspondent Contact DALE COLEMAN
Regulation Number876.5320
Classification Product Code
KPI  
Subsequent Product Code
HIR  
Date Received11/03/1999
Decision Date 11/29/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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