FDA 510(k) Application Details - K000748

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K000748
Device Name	Condom
Applicant	ARMKEL, LLC. P.O. BOX 1001, HALF ACRE RD. CRANBURY, NJ 08512 US Other 510(k) Applications for this Company
Contact	STEPHEN C KOLAKOWSKY 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	03/08/2000
Decision Date	04/06/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review