510(k) K020654 ยท PAG Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
STRATASIS SLING KIT
| Applicant | Cook Biotech, Inc., West Lafayette IN, US |
| Decision | Substantially Equivalent, Apr 9, 2002 |
| Received | Feb 28, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020654
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.