The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Tyrx Absorbable Antibacterial Envelope (medium), Tyrx Absorbable Antibacterial Envelope (large).
| Device ID | K192389 |
| 510k Number | K192389 |
| Device Name: | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Nancy Cameron |
| Correspondent | Nancy Cameron Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2019-09-03 |
| Decision Date | 2020-03-27 |