FDA 510(k) Application Details - K232279

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K232279
Device Name	Condom
Applicant	Suretex Limited 31/1 Moo 4, Suratthani-Thakuapha Road Tambon Khao Kwai, Amphur Phunphin 84130 TH Other 510(k) Applications for this Company
Contact	Alison Arnot 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	07/31/2023
Decision Date	10/05/2023
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