The following data is part of a premarket notification filed by Tei Biosciences Inc. with the FDA for Primatrix Dermal Repair Scaffold.
| Device ID | K153690 |
| 510k Number | K153690 |
| Device Name: | PriMatrix Dermal Repair Scaffold |
| Classification | Dressing, Wound, Collagen |
| Applicant | TEI BioSciences Inc. 7 Elkins Street Boston, MD 02127 |
| Contact | David D Cox |
| Correspondent | David D Cox Integra LifeSciences Corp (Owner Of TEI BioSciences) 311 Enterprise Drive Plainsboro, NJ 08536 |
| 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 | 2015-12-23 |
| Decision Date | 2016-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780357421 | K153690 | 000 |
| 10381780113447 | K153690 | 000 |
| 10381780113430 | K153690 | 000 |
| 10381780113423 | K153690 | 000 |
| 10381780113409 | K153690 | 000 |
| 10381780113393 | K153690 | 000 |
| 10381780113386 | K153690 | 000 |
| 10381780113379 | K153690 | 000 |
| 10381780113362 | K153690 | 000 |
| 10381780113355 | K153690 | 000 |
| 10381780113348 | K153690 | 000 |
| 10381780113331 | K153690 | 000 |
| 10381780113324 | K153690 | 000 |
| 10381780113317 | K153690 | 000 |
| 10381780113300 | K153690 | 000 |
| 10381780113454 | K153690 | 000 |
| 10381780113461 | K153690 | 000 |
| 10381780113478 | K153690 | 000 |
| 10381780357414 | K153690 | 000 |
| 10381780357407 | K153690 | 000 |
| 10381780113751 | K153690 | 000 |
| 10381780113744 | K153690 | 000 |
| 10381780113737 | K153690 | 000 |
| 10381780113720 | K153690 | 000 |
| 10381780113713 | K153690 | 000 |
| 10381780113706 | K153690 | 000 |
| 10381780113690 | K153690 | 000 |
| 10381780113683 | K153690 | 000 |
| 10381780113676 | K153690 | 000 |
| 10381780113669 | K153690 | 000 |
| 10381780113652 | K153690 | 000 |
| 10381780113485 | K153690 | 000 |
| 10381780113294 | K153690 | 000 |