The following data is part of a premarket notification filed by Caldera Medical, Inc. with the FDA for Desara Mesh Sling, Model Cal-ds01.
| Device ID | K072456 |
| 510k Number | K072456 |
| Device Name: | DESARA MESH SLING, MODEL CAL-DS01 |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | CALDERA MEDICAL, INC. 1205 DE LA VINA Santa Barbara, CA 93101 |
| Contact | Christine Emanuel |
| Correspondent | Christine Emanuel CALDERA MEDICAL, INC. 1205 DE LA VINA Santa Barbara, CA 93101 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-31 |
| Decision Date | 2008-05-08 |
| Summary: | summary |