FDA 510(k) Application Details - K042915

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K042915
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	O'MY PRODUCTS INCORPORATED 188 PEMBERTON AVENUE NORTH VANCOUVER V7P 2R5 CA Other 510(k) Applications for this Company
Contact	ROB LOGAN 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	10/21/2004
Decision Date	08/31/2005
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