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 | K132699 |
| 510k Number | K132699 |
| Device Name: | AIGIS RX N (MEDIUM), AIGIS RX N (LARGE) |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | TYRX , INC. 1 DEER PARK DR. SUITE G Monmouth Junction, NJ 08852 |
| Contact | Regina Novak |
| Correspondent | Regina Novak TYRX , 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 | 2013-08-29 |
| Decision Date | 2013-11-26 |
| Summary: | summary |