FDA 510(k) Application Details - K171213

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K171213
Device Name	Condom
Applicant	Thai Nippon Rubber Industry Public Company Limited 1 Charoenrat Road, Thungwatdon, Sathon Bangkok 10120 TH Other 510(k) Applications for this Company
Contact	Pisut Chanwatarungkull (Pete) 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	04/25/2017
Decision Date	01/12/2018
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