FDA 510(k) Application Details - K212104

Device Classification Name	Lubricant, Patient, Vaginal, Latex Compatible   More FDA Info for this Device
510(K) Number	K212104
Device Name	Lubricant, Patient, Vaginal, Latex Compatible
Applicant	Foshan PingChuang Medical Technology Co., Ltd. Room 301, No. 3, Huaye Road, Lingang Pioneer Park, Shunjiang Neighborhood Committee, Beijiao Foshan 528312 CN Other 510(k) Applications for this Company
Contact	Huang Zhiyue 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	07/06/2021
Decision Date	11/18/2021
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