The following data is part of a premarket notification filed by Caldera Medical, Inc. with the FDA for Desara Tv, Desara Blue Tv.
| Device ID | K162201 |
| 510k Number | K162201 |
| Device Name: | Desara TV, Desara Blue TV |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| 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 | OTN |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-05 |
| Decision Date | 2017-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00890594000803 | K162201 | 000 |
| 00890594000919 | K162201 | 000 |
| 00890594000841 | K162201 | 000 |