FDA 510(k) Application Details - K994095

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K994095
Device Name	Condom
Applicant	THAI NIPPON RUBBER INDUSTRY CO., LTD. 1219 LITTLE CREEK RD. DURHAM, NC 27713 US Other 510(k) Applications for this Company
Contact	ELI J CARTER 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	12/03/1999
Decision Date	01/18/2000
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