FDA 510(k) Application Details - K121857

Device Classification Name	Cup, Menstrual   More FDA Info for this Device
510(K) Number	K121857
Device Name	Cup, Menstrual
Applicant	FEMCAP INCORPORATED 27001 LA PAZ ROAD, SUITE 312 MISSION VIEJO, CA 92691 US Other 510(k) Applications for this Company
Contact	ALBERT REGO 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	06/26/2012
Decision Date	11/15/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review