FDA 510(k) Application Details - K042603

Device Classification Name	More FDA Info for this Device
510(K) Number	K042603
Device Name	GYNECARE PROLENE FASTENER SYSTEM
Applicant	ETHICON, INC. P.O BOX 151, ROUTE 22 WEST SOMERVILLE, NJ 08876 US Other 510(k) Applications for this Company
Contact	SEAN O'BRYAN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/24/2004
Decision Date	12/22/2004
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