FDA 510(k) Application Details - K233361

Device Classification Name	Cup, Menstrual   More FDA Info for this Device
510(K) Number	K233361
Device Name	Cup, Menstrual
Applicant	Menstrual Mates 16192 Coastal Highway Lewes, DE 19958 US Other 510(k) Applications for this Company
Contact	Cindy Belardo Other 510(k) Applications for this Contact
Regulation Number	884.5400   More FDA Info for this Regulation Number
Classification Product Code	HHE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2023
Decision Date	06/21/2024
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