FDA 510(k) Application Details - K240081

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K240081
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	Jiangxi Wulinxiang Biological Technology Co., Ltd. 1F,Building 1,Nanchang LED Industry Innovation Demonstration Park, No. 1111 Changdong Avenue, Qingshan Nanchang 330012 CN Other 510(k) Applications for this Company
Contact	Yang Qi 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	01/11/2024
Decision Date	08/16/2024
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