FDA 510(k) Application Details - K141132

Device Classification Name	More FDA Info for this Device
510(K) Number	K141132
Device Name	ASTROGLIDE TTC FERTILITY FRIENDLY PERSONAL LUBRICANT
Applicant	BIOFILM, INC. 3225 Executive Rdg VISTA, CA 92081 US Other 510(k) Applications for this Company
Contact	Sherry Castello Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PEB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/01/2014
Decision Date	01/09/2015
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