The following data is part of a premarket notification filed by Alure Medical Inc. with the FDA for Refine Support System, Model 100.0100.
| Device ID | K092538 |
| 510k Number | K092538 |
| Device Name: | REFINE SUPPORT SYSTEM, MODEL 100.0100 |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | ALURE MEDICAL INC. 3637 WESTWIND BLVD., SUITE B Santa Rosa, CA 95403 |
| Contact | Joseph Tamayo |
| Correspondent | Joseph Tamayo ALURE MEDICAL INC. 3637 WESTWIND BLVD., SUITE B Santa Rosa, CA 95403 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-19 |
| Decision Date | 2010-03-05 |
| Summary: | summary |