The following data is part of a premarket notification filed by Caldera Medical, Inc. with the FDA for Desara Mesh Model: Cal-ds01.
| Device ID | K101169 |
| 510k Number | K101169 |
| Device Name: | DESARA MESH MODEL: CAL-DS01 |
| Classification | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator |
| Applicant | CALDERA MEDICAL, INC. 28632 ROADSIDE DR., SUITE 260 Agoura Hills, CA 91301 |
| Contact | Vicki Gail |
| Correspondent | Vicki Gail CALDERA MEDICAL, INC. 28632 ROADSIDE DR., SUITE 260 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 | 2010-04-26 |
| Decision Date | 2010-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00890594000049 | K101169 | 000 |