510(k) K032893 ยท FTL Mesh, Surgical, Polymeric
SHELHIGH NO-REACT BIOCUFF
| Applicant | Shelhigh, Inc., Union NJ, US |
| Decision | Substantially Equivalent, Dec 19, 2003 |
| Received | Sep 17, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K032893
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.