The following data is part of a premarket notification filed by Caldera Medical with the FDA for Desara Blue Ov, Desara Blue Ss.
| Device ID | K140843 |
| 510k Number | K140843 |
| Device Name: | DESARA BLUE OV, DESARA BLUE SS |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| 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 | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-02 |
| Decision Date | 2014-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00890594000728 | K140843 | 000 |
| 00890594000698 | K140843 | 000 |