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 | K060984 |
| 510k Number | K060984 |
| Device Name: | XENFORM SOFT TISSUE REPAIR MATRIX |
| Classification | Mesh, Surgical |
| 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 | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-10 |
| Decision Date | 2006-05-17 |
| Summary: | summary |