The following data is part of a premarket notification filed by Tyrx Pharma Inc with the FDA for Tyrx Surgical Mesh, Model Smpc-0501.
| Device ID | K052864 |
| 510k Number | K052864 |
| Device Name: | TYRX SURGICAL MESH, MODEL SMPC-0501 |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | TYRX PHARMA INC 1 DEER PARK DR SUITE G Monmouth Junction, NJ 08852 |
| Contact | Mason W Diamond |
| Correspondent | Mason W Diamond TYRX PHARMA INC 1 DEER PARK DR 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 | No |
| Date Received | 2005-10-11 |
| Decision Date | 2005-12-22 |
| Summary: | summary |