FDA 510(k) Application Details - K063562

Device Classification Name	More FDA Info for this Device
510(K) Number	K063562
Device Name	GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS
Applicant	ETHICON, INC. P.O. BOX 151 ROUTE 22 WEST SOMERVILLE, NJ 08876 US Other 510(k) Applications for this Company
Contact	PATRICE NAGODA Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2006
Decision Date	02/26/2007
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