The following data is part of a premarket notification filed by Tei Biosciences Inc. with the FDA for Primatrix Ag Antimicrobial Dermal Dermal Repair Scaffold.
| Device ID | K100261 |
| 510k Number | K100261 |
| Device Name: | PRIMATRIX AG ANTIMICROBIAL DERMAL DERMAL REPAIR SCAFFOLD |
| Classification | Dressing, Wound, Drug |
| 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 | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2010-01-28 |
| Decision Date | 2010-12-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780257776 | K100261 | 000 |
| 10381780113584 | K100261 | 000 |
| 10381780113577 | K100261 | 000 |
| 10381780113560 | K100261 | 000 |
| 10381780113553 | K100261 | 000 |
| 10381780113546 | K100261 | 000 |
| 10381780113539 | K100261 | 000 |
| 10381780113522 | K100261 | 000 |
| 10381780113515 | K100261 | 000 |
| 10381780113508 | K100261 | 000 |
| 10381780113591 | K100261 | 000 |
| 10381780113607 | K100261 | 000 |
| 10381780177739 | K100261 | 000 |
| 10381780177722 | K100261 | 000 |
| 10381780177715 | K100261 | 000 |
| 10381780177708 | K100261 | 000 |
| 10381780177685 | K100261 | 000 |
| 10381780113782 | K100261 | 000 |
| 10381780113775 | K100261 | 000 |
| 10381780113768 | K100261 | 000 |
| 10381780113614 | K100261 | 000 |
| 10381780113492 | K100261 | 000 |