FDA 510(k) Application Details - K182100

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K182100
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	LFBeauty (Thailand) Limited 21/7 Moo 6 Kookot Lamlukka 12130 TH Other 510(k) Applications for this Company
Contact	Apasara Kaewlor 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	08/03/2018
Decision Date	04/25/2019
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