FDA 510(k) Application Details - K954791

Device Classification Name	Condom   More FDA Info for this Device
510(K) Number	K954791
Device Name	Condom
Applicant	APEX MEDICAL TECHNOLOGIES, INC. 10064 MESA RIDGE CT., #202 SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	STEFANIE BEDARD 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	10/18/1995
Decision Date	01/05/1996
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