FDA 510(k) Application Details - K213921

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K213921
Device Name	Condom
Applicant	Suretex Limited 31/1 Moo 4, Suratthani-Thakuapha Road Tambon Khao Hua Kwai, Amphur Phunphin 84130 TH Other 510(k) Applications for this Company
Contact	KC Nguyen 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	12/15/2021
Decision Date	04/28/2022
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