FDA 510(k) Application Details - K240798

Device Classification Name	Pessary, Vaginal   More FDA Info for this Device
510(K) Number	K240798
Device Name	Pessary, Vaginal
Applicant	Cntrl+ Inc. 501 Campbell St. Unit 3B Cornwall K6H6X5 CA Other 510(k) Applications for this Company
Contact	Karen Brunet 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	03/22/2024
Decision Date	12/17/2024
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