The following data is part of a premarket notification filed by Tei Biosciences Inc. with the FDA for Surgimend Mp Collagen Matrix For Soft Tissue Reconstruction.
| Device ID | K162965 |
| 510k Number | K162965 |
| Device Name: | SurgiMend MP Collagen Matrix For Soft Tissue Reconstruction |
| Classification | Mesh, Surgical |
| Applicant | TEI Biosciences Inc. 7 Elkins Street Boston, MA 02127 |
| Contact | Kavita Amin |
| Correspondent | Kavita Amin Integra LifeSciences Corporation (Owner Of TEI Biosciences) 311 Enterprise Drive Plainsboro, NJ 08536 |
| Product Code | FTM |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-24 |
| Decision Date | 2017-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780357391 | K162965 | 000 |
| 10381780357384 | K162965 | 000 |
| 10381780357377 | K162965 | 000 |
| 10381780357360 | K162965 | 000 |
| 10381780357353 | K162965 | 000 |
| 10381780357346 | K162965 | 000 |
| 10381780357339 | K162965 | 000 |