The following data is part of a premarket notification filed by Tyrx ,inc with the FDA for Aigis Rx N Medium; Aigis Rx N Large.
| Device ID | K131007 |
| 510k Number | K131007 |
| Device Name: | AIGIS RX N MEDIUM; AIGIS RX N LARGE |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | TYRX ,INC 1 DEER PARK DRIVE SUITE G Monmouth Junction, NJ 08852 |
| Contact | Susan Olinger |
| Correspondent | Susan Olinger 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 | 2013-04-11 |
| Decision Date | 2013-07-10 |
| Summary: | summary |