INCONTROL


Device Classification Name

stimulator, electrical, non-implantable, for incontinence

510(k) Number 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

Correspodent Contact michael leigh
Regulation Number 876.5320
Classification Product Code
KPI  
Date Received 01/21/2011
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