FDA 510(k) Application Details - K140626

Device Classification Name	Cup, Menstrual   More FDA Info for this Device
510(K) Number	K140626
Device Name	Cup, Menstrual
Applicant	MELUNA 1468 HARWELL AVE CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	YOLANDA SMITH 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	03/11/2014
Decision Date	07/10/2014
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