FDA 510(k) Application Details - K191411

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K191411
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	Bio-Tech Lubricants Ltd C/O Epsilon House, Enterprise Road, Southampton Science Park Southampton SO16 7NS GB Other 510(k) Applications for this Company
Contact	Sarah Brooks 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	05/28/2019
Decision Date	02/06/2020
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