The following data is part of a premarket notification filed by Caldera Medical, Inc. with the FDA for Ascend Blue Ac Mesh; Ascend Blue Pc Mesh.
| Device ID | K101462 |
| 510k Number | K101462 |
| Device Name: | ASCEND BLUE AC MESH; ASCEND BLUE PC MESH |
| Classification | Mesh, Surgical, Polymeric |
| Applicant | CALDERA MEDICAL, INC. 28632 ROADSIDE DR., SUITE 260 Agoura Hills, CA 91301 -6099 |
| Contact | Vicki Gail |
| Correspondent | Vicki Gail CALDERA MEDICAL, INC. 28632 ROADSIDE DR., SUITE 260 Agoura Hills, CA 91301 -6099 |
| Product Code | FTL |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-26 |
| Decision Date | 2010-08-16 |
| Summary: | summary |