FDA 510(k) Application Details - K242712

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K242712
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	SK Zen LLC 1264 Bayview Cir Weston, FL 33326 US Other 510(k) Applications for this Company
Contact	Yasminka Jurisic 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	09/09/2024
Decision Date	06/04/2025
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