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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 K110179
FOIA Releasable 510(k) K110179
Device Name INCONTROL
Applicant
INCONTROL MEDICAL, LLC
12715 FALCON DRIVE
BROOKFIELD,  WI  53005
Applicant Contact MICHAEL LEIGH
Correspondent
INCONTROL MEDICAL, LLC
12715 FALCON DRIVE
BROOKFIELD,  WI  53005
Correspondent Contact MICHAEL LEIGH
Regulation Number876.5320
Classification Product Code
KPI  
Date Received01/21/2011
Decision Date 02/22/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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