The following data is part of a premarket notification filed by Tyrx , Inc. with the FDA for Aigis Rx R Pm/ Aigis Rx R Icd.
| Device ID | K130943 |
| 510k Number | K130943 |
| Device Name: | AIGIS RX R PM/ AIGIS RX R ICD |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | TYRX , INC. 1 DEER PARK DR. SUITE G Monmouth Junction, NJ 08852 |
| Contact | Susan Olinger |
| Correspondent | Susan Olinger 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 | 2013-04-04 |
| Decision Date | 2013-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169935907 | K130943 | 000 |
| 00643169935891 | K130943 | 000 |
| 00643169468856 | K130943 | 000 |
| 00643169468795 | K130943 | 000 |