FDA 510(k) Application Details - K971028

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K971028
Device Name	Condom
Applicant	WORLDS-BEST GUMMIVAREFABRIK A/S 15 RUDOLFGAARDSVEJ VIBY J. 8260 DK Other 510(k) Applications for this Company
Contact	CHRISTIAN HJORTH 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	03/20/1997
Decision Date	03/02/1998
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