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FDA 510(k) Application Details - K182022
Device Classification Name
Stimulator, Electrical, Non-Implantable, For Incontinence
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510(K) Number
K182022
Device Name
Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant
InControl Medical, LLC
3225 Gateway Road Suite 250
Brookfield, WI 53045 US
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Contact
Corey Olson
Other 510(k) Applications for this Contact
Regulation Number
876.5320
More FDA Info for this Regulation Number
Classification Product Code
KPI
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More FDA Info for this Product Code
Date Received
07/27/2018
Decision Date
03/15/2019
Decision
SESK - SUBST EQUIV - KIT
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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