The following data is part of a premarket notification filed by Caldera Medical, Inc. with the FDA for Desara Tv Ez 3.0 System, Desara Blue Tv Ez 3.0 System, Desara Tv Ez 2.7 System, Desara Blue Tv Ez 2.7 System.
| Device ID | K211975 |
| 510k Number | K211975 |
| Device Name: | Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | Caldera Medical, Inc. 4360 Park Terrace Drive Westlake Village, CA 91361 |
| Contact | Vicki Gail |
| Correspondent | Vicki Gail Caldera Medical, Inc. 4360 Park Terrace Drive Westlake Village, CA 91361 |
| Product Code | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-25 |
| Decision Date | 2021-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00890594000117 | K211975 | 000 |
| 00890594000100 | K211975 | 000 |
| 00890594000094 | K211975 | 000 |
| 00890594000087 | K211975 | 000 |
| 00890594000193 | K211975 | 000 |
| 00890594000155 | K211975 | 000 |
| 00890594000131 | K211975 | 000 |
| 00890594000124 | K211975 | 000 |