FDA 510(k) Application Details - K163395

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K163395
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	BioFilm, Inc. 3225 Executive Ridge Vista, CA 92081 US Other 510(k) Applications for this Company
Contact	Richard Hines 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	12/05/2016
Decision Date	02/10/2017
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