510(k) K162201 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Desara TV, Desara Blue TV
| Applicant | Caldera Medical, Inc., Agoura Hills CA, US |
| Decision | Substantially Equivalent, Jan 11, 2017 |
| Received | Aug 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162201
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.