FDA 510(k) Application Details - K061466

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K061466
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	DLC LABORATORIES, INC. 7008 MARCELLE STREET PARAMOUNT, CA 90723 US Other 510(k) Applications for this Company
Contact	JUAN MANZUR 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	05/26/2006
Decision Date	12/04/2006
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