FDA 510(k) Application Details - K250034

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K250034
Device Name	Condom
Applicant	Shaoguan Regenex Pharmaceuticals Co., Ltd. No.9, Gantang Ninth Road, Wujiang District, Shaoguan CN Other 510(k) Applications for this Company
Contact	Kangwei Pan Other 510(k) Applications for this Contact
Regulation Number	884.5300   More FDA Info for this Regulation Number
Classification Product Code	HIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/07/2025
Decision Date	07/11/2025
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