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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 K053434
Device Name MYOTRAC INFINITI ELECTRICAL STIMULATOR
Applicant
Thought Technology , Ltd.
2180 Belgrave Ave.
Montreal, Quebec,  CA H4A 2LB
Applicant Contact SURESH R SUGIRTHARAJA
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Correspondent Contact ROBERT MOSENKIS
Regulation Number876.5320
Classification Product Code
KPI  
Subsequent Product Codes
HCC   IPF  
Date Received12/09/2005
Decision Date 03/15/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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