FDA 510(k) Application Details - K990597

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K990597
Device Name	Condom
Applicant	C.B. FLEET CO., INC. 1050 CONNECTICUT AVENUE N.W. WASHINGTON, DC 20036 US Other 510(k) Applications for this Company
Contact	PETER S REICHERTZ 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	02/24/1999
Decision Date	07/19/1999
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