The following data is part of a premarket notification filed by Ariste Medical Llc with the FDA for Ariste Ab Mesh.
| Device ID | K211132 |
| 510k Number | K211132 |
| Device Name: | ARISTE AB Mesh |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | Ariste Medical LLC 9950 S 300 W Sandy, UT 84070 |
| Contact | Olaf Schulz |
| Correspondent | Brian Young Health Policy Associates Inc 690 Canton Street, Suite 302 Westwood, MA 02492 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2021-04-16 |
| Decision Date | 2022-03-18 |