The following data is part of a premarket notification filed by Caldera Medical with the FDA for Vertessa Lite 10 X 20cm, Vertessa Lite 11 X 30cm.
| Device ID | K123337 |
| 510k Number | K123337 |
| Device Name: | VERTESSA LITE 10 X 20CM, VERTESSA LITE 11 X 30CM |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Applicant | CALDERA MEDICAL 5171 Clareton Dr Agoura Hills, CA 91301 |
| Contact | Vicki Gail |
| Correspondent | Vicki Gail CALDERA MEDICAL 5171 Clareton Dr Agoura Hills, CA 91301 |
| Product Code | OTO |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-31 |
| Decision Date | 2013-02-21 |
| Summary: | summary |