The following data is part of a premarket notification filed by Tyrx ,inc with the FDA for Pivit A/b St And Pivit A/b St-r.
| Device ID | K093524 |
| 510k Number | K093524 |
| Device Name: | PIVIT A/B ST AND PIVIT A/B ST-R |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | TYRX ,INC 1 DEER PARK DRIVE SUITE G Monmouth Junction, NJ 08852 |
| Contact | Mark Citron |
| Correspondent | Mark Citron 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 | No |
| Date Received | 2009-11-16 |
| Decision Date | 2010-03-26 |
| Summary: | summary |