The following data is part of a premarket notification filed by Tei Biosciences Inc. with the FDA for Xenform Soft Tissue Repair Matrix.
| Device ID | K051190 |
| 510k Number | K051190 |
| Device Name: | XENFORM SOFT TISSUE REPAIR MATRIX |
| Classification | Mesh, Surgical, Non-synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Applicant | TEI BIOSCIENCES INC. 7 ELKINS ST. Boston, MA 02127 |
| Contact | Kenneth James |
| Correspondent | Kenneth James TEI BIOSCIENCES INC. 7 ELKINS ST. Boston, MA 02127 |
| Product Code | PAJ |
| Subsequent Product Code | PAG |
| Subsequent Product Code | PAI |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-10 |
| Decision Date | 2005-06-10 |
| Summary: | summary |