510(k) Premarket Notification

• Device Classification Name: mesh, surgical
• 510(K) Number: K062915
• Device Name: VERITAS COLLAGEN MATRIX
• Applicant: SYNOVIS SURGICAL INNOVATIONS; 2575 university ave.; st. paul, MN 55114 1024
• Contact: cynthia lamarucciola
• Regulation Number: 878.3300
• Classification Product Code: FTM
• Subsequent Product Codes: OXB OXE PAI
• Date Received: 09/28/2006
• Decision Date: 12/06/2006
• 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