FDA 510(k) Application Details - K232677

Device Classification Name	Pessary, Vaginal   More FDA Info for this Device
510(K) Number	K232677
Device Name	Pessary, Vaginal
Applicant	Reia, LLC 331 River Road Lyme, NH 03768 US Other 510(k) Applications for this Company
Contact	Kaitlin Maier 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	09/01/2023
Decision Date	05/21/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review