510(k) Premarket Notification

• Device Classification Name: mesh, surgical, non-synthetic, urogynecologic, for apical vaginal and uterine prolapse, transabdominally placed
• 510(K) Number: K051190
• Device Name: XENFORM SOFT TISSUE REPAIR MATRIX
• Applicant: TEI BIOSCIENCES INC.; 7 elkins st.; boston, MA 02127
• Contact: kenneth james
• Regulation Number: 878.3300
• Classification Product Code: PAJ
• Subsequent Product Codes: PAG PAI
• Date Received: 05/13/2005
• Decision Date: 06/10/2005
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Obstetrics/Gynecology
• Review Advisory Committee: General & Plastic Surgery
• summary: summary
• Type: Special
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No