FDA 510(k) Application Details - K021737

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K021737
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	COLUMBIA LABORATORIES, INC. 100 NORTH VILLAGE AVE. SUITE 32 ROCKVILLE CENTRE, NY 11570 US Other 510(k) Applications for this Company
Contact	SUSAN A WITHAM Other 510(k) Applications for this Contact
Regulation Number	884.5300   More FDA Info for this Regulation Number
Classification Product Code	NUC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2002
Decision Date	08/26/2002
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