The following data is part of a premarket notification filed by Caldera Medical, Inc. with the FDA for Vertessa Lite.
| Device ID | K150016 |
| 510k Number | K150016 |
| Device Name: | Vertessa Lite |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed |
| Applicant | CALDERA MEDICAL, INC. 5171 CLARETON DRIVE Agoura Hills, CA 91301 |
| Contact | Vicki Gail |
| Correspondent | Vicki Gail CALDERA MEDICAL, INC. 5171 CLARETON DRIVE 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 | 2015-01-05 |
| Decision Date | 2015-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00890594000384 | K150016 | 000 |
| 00890594000360 | K150016 | 000 |
| 00890594000643 | K150016 | 000 |