510(k) Premarket Notification

• Device Classification Name: mesh, surgical, absorbable, abdominal hernia
• 510(K) Number: K120728
• Model: 1190600, 1190601, 1190602, 1190603
• Device Name: PHASIX PLUG AND PATCH
• Applicant: C.R. BARD INC; 100 crossings boulevard; warwick, RI 02886
• Contact: sherma winston
• Regulation Number: 878.3300
• Classification Product Code: OWT
• Subsequent Product Code: OOD
• Date Received: 03/09/2012
• Decision Date: 10/22/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: General & Plastic Surgery
• Review Advisory Committee: General & Plastic Surgery
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No