The following data is part of a premarket notification filed by Alure Medical Inc. with the FDA for Refine Lift System.
| Device ID | K083102 |
| 510k Number | K083102 |
| Device Name: | REFINE LIFT SYSTEM |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ALURE MEDICAL INC. 2445 IMPALA DR. Carlsbad, CA 92010 |
| Contact | Jasper Benke |
| Correspondent | Jasper Benke ALURE MEDICAL INC. 2445 IMPALA DR. Carlsbad, CA 92010 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-20 |
| Decision Date | 2009-05-11 |
| Summary: | summary |