510(k) K101169 ยท OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
DESARA MESH MODEL: CAL-DS01
| Applicant | Caldera Medical, Inc., Agoura Hills CA, US |
| Decision | Substantially Equivalent, May 20, 2010 |
| Received | Apr 26, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101169
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.