FDA 510(k) Application Details - K040085

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K040085
Device Name	Condom
Applicant	QUALIS, INC. 4600 PARK AVE. DES MOINES, IA 50321 US Other 510(k) Applications for this Company
Contact	MIKE PETERSON 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	01/16/2004
Decision Date	04/20/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OB - Obstetrics/Gynecology
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review