FDA 510(k) Application Details - K040428

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K040428
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	R & K INTERNATIONAL COSMETICS 1020 19TH STREET NW SUITE 400 WASHINGTON, DC 20036 US Other 510(k) Applications for this Company
Contact	GARYN L LOTRIDGE 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	02/19/2004
Decision Date	08/09/2005
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