FDA 510(k) Application Details - K150841

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K150841
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	LACLEDE, INC. 2103 EAST UNIVERSITY DR. RANCHO DOMINQUEZ, CA 90220 US Other 510(k) Applications for this Company
Contact	Michael Pellico 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	03/30/2015
Decision Date	12/29/2015
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