FDA 510(k) Application Details - K222611

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K222611
Device Name	Condom
Applicant	Suzhou Colour-way New Material Co., Ltd. No. 20, Anmin Road, Huangdai Town, Xiangcheng District Suzhou 215152 CN Other 510(k) Applications for this Company
Contact	Yongping Xu 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	08/30/2022
Decision Date	11/28/2022
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