FDA 510(k) Application Details - K971793

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K971793
Device Name	Condom
Applicant	BRANDWYNNE CORP. 649 STONE CANYON RD. LOS ANGELES, CA 90077 US Other 510(k) Applications for this Company
Contact	JACQUELINE B BRADWYNNE 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	05/15/1997
Decision Date	11/24/1997
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