The following data is part of a premarket notification filed by Tyrx Pharma Inc with the FDA for Tyrx Antimicrobial Mesh.
| Device ID | K053656 |
| 510k Number | K053656 |
| Device Name: | TYRX ANTIMICROBIAL MESH |
| 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 | Yes |
| Date Received | 2005-12-30 |
| Decision Date | 2006-07-14 |
| Summary: | summary |