The following data is part of a premarket notification filed by Tyrx, Inc. with the FDA for Tyrx Neuro Antibacterial Envelope.
| Device ID | K152678 |
| 510k Number | K152678 |
| Device Name: | TYRX Neuro Antibacterial Envelope |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | TYRX, INC. 1 DEER PARK DRIVE SUITE G Monmouth Junction, NJ 08852 |
| Contact | Regina Novak |
| Correspondent | Regina Novak 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 | 2015-09-18 |
| Decision Date | 2015-11-17 |
| Summary: | summary |