The following data is part of a premarket notification filed by Tei Biosciences Inc. with the FDA for Primatrix Dermal Repair Scaffold.
| Device ID | K131286 |
| 510k Number | K131286 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-06 |
| Decision Date | 2013-08-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780113751 | K131286 | 000 |
| 10381780113423 | K131286 | 000 |
| 10381780113416 | K131286 | 000 |
| 10381780113409 | K131286 | 000 |
| 10381780113393 | K131286 | 000 |
| 10381780113386 | K131286 | 000 |
| 10381780113379 | K131286 | 000 |
| 10381780113362 | K131286 | 000 |
| 10381780113355 | K131286 | 000 |
| 10381780113348 | K131286 | 000 |
| 10381780113331 | K131286 | 000 |
| 10381780113324 | K131286 | 000 |
| 10381780113300 | K131286 | 000 |
| 10381780113294 | K131286 | 000 |
| 10381780113430 | K131286 | 000 |
| 10381780113447 | K131286 | 000 |
| 10381780113454 | K131286 | 000 |
| 10381780113744 | K131286 | 000 |
| 10381780113737 | K131286 | 000 |
| 10381780113720 | K131286 | 000 |
| 10381780113713 | K131286 | 000 |
| 10381780113706 | K131286 | 000 |
| 10381780113690 | K131286 | 000 |
| 10381780113683 | K131286 | 000 |
| 10381780113676 | K131286 | 000 |
| 10381780113669 | K131286 | 000 |
| 10381780113652 | K131286 | 000 |
| 10381780113485 | K131286 | 000 |
| 10381780113478 | K131286 | 000 |
| 10381780113461 | K131286 | 000 |
| 10381780113317 | K131286 | 000 |