FDA 510(k) Application Details - K192779

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K192779
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	Reoxcyn, LLC 1488 west Pleasant View Drive, Sutie 150 Pleasant Grove, UT 84062 US Other 510(k) Applications for this Company
Contact	Ellie Hartz 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	09/30/2019
Decision Date	06/02/2020
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review