FDA 510(k) Application Details - K152646

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K152646
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	TORO MANAGEMENT LLC DBA SYLK 7272 EAST INDIAN SCHOOL ROAD SUITE 540 SCOTTSDALE, AZ 85251 US Other 510(k) Applications for this Company
Contact	MARIESSA MAHFOUZ 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	09/16/2015
Decision Date	03/11/2016
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