510(k) K043035 ยท KHJ Polymer, Ent Synthetic-Polyamide (Mesh Or Foil Material)
SEPRAGEL ENT BIORESORBABLE PACKING/STENT
| Applicant | Genzyme Corporation, Cambridge MA, US |
| Decision | Substantially Equivalent, Jul 11, 2005 |
| Received | Nov 3, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043035
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.