FDA 510(k) Application Details - K963321

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K963321
Device Name	Condom
Applicant	CUSTOM SERVICES INTL., INC. 3111 WEST POST RD. LAS VEGAS, NV 89118 US Other 510(k) Applications for this Company
Contact	LILLIE C THOMAS, M.S. 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	08/12/1996
Decision Date	01/22/1997
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