FDA 510(k) Application Details - K153016

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K153016
Device Name	Condom
Applicant	Guangzhou Daming United Rubber Products Ltd. NO. 1 Daming Street, Port Industrial Zone Huada District Guangzhou 510802 CN Other 510(k) Applications for this Company
Contact	Yongbing Xie 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	10/15/2015
Decision Date	10/20/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review