FDA 510(k) Application Details - K112165

Device Classification Name	Cup, Menstrual   More FDA Info for this Device
510(K) Number	K112165
Device Name	Cup, Menstrual
Applicant	APEX MEDICAL TECHNOLOGIES, INC. 10064 MESA RIDGE CT., #202 SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	SCOTT HERRICK 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	07/28/2011
Decision Date	05/24/2012
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