FDA 510(k) Application Details - K960710

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K960710
Device Name	Condom
Applicant	POLAR LATEX LTD. P.O. BOX 1673 JULIAN, CA 92036 US Other 510(k) Applications for this Company
Contact	JULIA ERICKSON 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	02/21/1996
Decision Date	10/10/1996
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