The following data is part of a premarket notification filed by Caldera Medical, Inc. with the FDA for Caldera Mesh.
| Device ID | K060004 |
| 510k Number | K060004 |
| Device Name: | CALDERA MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | CALDERA MEDICAL, INC. 28632 ROADSIDE DR., SUITE 260 Agoura Hills, CA 91301 |
| Contact | Marla Kengen |
| Correspondent | Marla Kengen CALDERA MEDICAL, INC. 28632 ROADSIDE DR., SUITE 260 Agoura Hills, CA 91301 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-03 |
| Decision Date | 2006-02-22 |
| Summary: | summary |