FDA 510(k) Application Details - K001974

Device Classification Name	Condom, Synthetic   More FDA Info for this Device
510(K) Number	K001974
Device Name	Condom, Synthetic
Applicant	MAYER LABORATORIES 646 KENNEDY ST., BLDG. C OAKLAND, CA 94606 US Other 510(k) Applications for this Company
Contact	DAVID P MAYER Other 510(k) Applications for this Contact
Regulation Number	884.5300   More FDA Info for this Regulation Number
Classification Product Code	MOL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2000
Decision Date	10/24/2001
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