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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 K922562
Device Name STIMTECH PFX, CATALOG NUMBER 78-8540
Applicant
Stimtech Products
One Brigham St.
Marlborough,  MA  01752
Applicant Contact JAMES WASON
Correspondent
Stimtech Products
One Brigham St.
Marlborough,  MA  01752
Correspondent Contact JAMES WASON
Regulation Number876.5320
Classification Product Code
KPI  
Date Received06/01/1992
Decision Date 10/13/1993
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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