FDA 510(k) Application Details - K230780

Device Classification Name	Stimulator, Electrical, Non-Implantable, For Incontinence   More FDA Info for this Device
510(K) Number	K230780
Device Name	Stimulator, Electrical, Non-Implantable, For Incontinence
Applicant	Zimmer MedizinSysteme GmbH Junkersstrasse 9 Neu-Ulm 89231 DE Other 510(k) Applications for this Company
Contact	Ute Killet Other 510(k) Applications for this Contact
Regulation Number	876.5320   More FDA Info for this Regulation Number
Classification Product Code	KPI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/22/2023
Decision Date	10/05/2023
Decision	SESE - SUBST EQUIV
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