FDA 510(k) Application Details - K210857

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K210857
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	Shenzhen Huanqiu Xuebao Technology Co., Ltd. Room 303, Building 2, Lane 2, Jinjuxia Road, Bao'an Avenue Fuyong Street Bao'an District Shenzhen 518100 CN Other 510(k) Applications for this Company
Contact	Jiao Li 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	03/23/2021
Decision Date	09/24/2021
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