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 | K180030 |
| 510k Number | K180030 |
| Device Name: | TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Medtronic, Inc. 8200 Coral Sea St. NE Mounds View, MN 55112 |
| Contact | Nancy Cameron |
| Correspondent | Nancy Cameron Medtronic, Inc. 8200 Coral Sea St. 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 | 2018-01-03 |
| Decision Date | 2018-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000101619 | K180030 | 000 |
| 00763000101602 | K180030 | 000 |
| 00763000307882 | K180030 | 000 |
| 00763000307875 | K180030 | 000 |