FDA 510(k) Application Details - K161585

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K161585
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	Mano and Mano Proprietary Limited 286 Chesterville Road Moorabbin 3189 AU Other 510(k) Applications for this Company
Contact	Katrina Allen 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	06/08/2016
Decision Date	09/06/2016
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