FDA 510(k) Application Details - K232525

Device Classification Name	Pessary, Vaginal   More FDA Info for this Device
510(K) Number	K232525
Device Name	Pessary, Vaginal
Applicant	Watkins-Conti Products Inc. 3841 East Danforth Rd., Suite 109 Edmond, OK 78084 US Other 510(k) Applications for this Company
Contact	Allison L Watkins 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	08/21/2023
Decision Date	05/17/2024
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