FDA 510(k) Application Details - K070965

Device Classification Name	Cup, Menstrual   More FDA Info for this Device
510(K) Number	K070965
Device Name	Cup, Menstrual
Applicant	ALICIA INTERNATIONAL PTY LTD. P.O. BOX 1471 OXENFORD, QUEENSLAND 4210 AU Other 510(k) Applications for this Company
Contact	TOM STONE 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	04/05/2007
Decision Date	03/05/2008
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