FDA 510(k) Application Details - K233548

Device Classification Name	Pessary, Vaginal   More FDA Info for this Device
510(K) Number	K233548
Device Name	Pessary, Vaginal
Applicant	Resilia Inc. 644 Main Street Suite S400, P.O. Box 1368 Moncton E1C 1E2 CA Other 510(k) Applications for this Company
Contact	Sam Imbeault Other 510(k) Applications for this Contact
Regulation Number	884.3575   More FDA Info for this Regulation Number
Classification Product Code	HHW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/03/2023
Decision Date	04/03/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review