FDA 510(k) Application Details - K182027

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K182027
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	Trigg Laboratories DBA Wet International 4220 W Windmill Lane, Suite 140 Las Vegas, NV 89139 US Other 510(k) Applications for this Company
Contact	Simone Buntin 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	07/30/2018
Decision Date	11/21/2018
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