The following data is part of a premarket notification filed by Medtronic Tyrx, Inc. with the FDA for Tyrx Neuro Absorbable Antibacterial Envelope.
| Device ID | K150291 |
| 510k Number | K150291 |
| Device Name: | TYRX Neuro Absorbable Antibacterial Envelope |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | MEDTRONIC TYRX, INC. 1 DEER PARK DRIVE SUITE G Monmouth Junction, NJ 08852 |
| Contact | Regina Novak |
| Correspondent | Regina Novak MEDTRONIC TYRX, INC. 1 DEER PARK DRIVE SUITE G Monmouth Junction, NJ 08852 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2015-02-06 |
| Decision Date | 2015-03-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169983540 | K150291 | 000 |
| 00643169983533 | K150291 | 000 |
| 00643169624795 | K150291 | 000 |
| 00643169624788 | K150291 | 000 |