The following data is part of a premarket notification filed by Tei Biosciences Inc. with the FDA for Primatrix Dermal Repair Scaffold.
| Device ID | K083440 |
| 510k Number | K083440 |
| Device Name: | PRIMATRIX DERMAL REPAIR SCAFFOLD |
| Classification | Dressing, Wound, Collagen |
| 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 | KGN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-20 |
| Decision Date | 2008-12-12 |
| Summary: | summary |