510(k) Premarket Notification

• Device Classification Name: mesh, surgical, synthetic, urogynecologic, for pelvic organ prolapse, transvaginally placed
• 510(K) Number: K071512
• Device Name: GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS
• Applicant: ETHICON, INC.; route 22 west; p.o. box 151; somerville, NJ 08876 0151
• Contact: bryan a lisa
• Regulation Number: 878.3300
• Classification Product Code: OTP
• Date Received: 06/04/2007
• Decision Date: 05/15/2008
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Obstetrics/Gynecology
• Review Advisory Committee: General & Plastic Surgery
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No