FDA 510(k) Application Details - K982924

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K982924
Device Name	Condom
Applicant	LONDON INTL. LLC. 2926 COLUMBIA HWY. P.O. BOX 8308 DOTHAN, AL 36304 US Other 510(k) Applications for this Company
Contact	NEIL ANDERSON 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	08/20/1998
Decision Date	11/16/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review