FDA 510(k) Application Details - K210294

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K210294
Device Name	Condom
Applicant	Thai Nippon Rubber Industry Public Company Limited 789/139 Pinthong Industrial Estate Nongkham Sriracha 20230 TH Other 510(k) Applications for this Company
Contact	Ryosuke Takamiya 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	02/02/2021
Decision Date	09/23/2021
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