FDA 510(k) Application Details - K013718

Device Classification Name	More FDA Info for this Device
510(K) Number	K013718
Device Name	GYNEMESH PROLENE SOFT (POLYPROPYLENE) NONABSORBABLE SYNTHETIC SURGICAL MESH FOR PELVIC FLOOR REPAIR
Applicant	GYNECARE, A DIV. OF ETHICON, INC. P.O. BOX 151 SOMERVILLE, NJ 08876 US Other 510(k) Applications for this Company
Contact	GREGORY R JONES Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/08/2001
Decision Date	01/08/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OB - Obstetrics/Gynecology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review