FDA 510(k) Application Details - K143349

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K143349
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	POLICHEM S.A. VIA SENAGO 42D LUGANO-PAZZALLO 6912 CH Other 510(k) Applications for this Company
Contact	Daria Mari 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	11/24/2014
Decision Date	09/16/2015
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