FDA 510(k) Application Details - K091754

Device Classification Name	Cup, Menstrual   More FDA Info for this Device
510(K) Number	K091754
Device Name	Cup, Menstrual
Applicant	LUNE GROUP LTD. 1920 ARLINGTON PLACE MADISON, WI 53726 US Other 510(k) Applications for this Company
Contact	MORRIS WAXLER 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	06/16/2009
Decision Date	11/13/2009
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