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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 K850167
Device Name }IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR
Applicant
Urologics, Inc.
1538 Catron Ave., SE
Albuquerque,  NM  87123
Applicant Contact EDWIN H BARSIS
Correspondent
Urologics, Inc.
1538 Catron Ave., SE
Albuquerque,  NM  87123
Correspondent Contact EDWIN H BARSIS
Regulation Number876.5320
Classification Product Code
KPI  
Date Received01/16/1985
Decision Date 04/09/1985
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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