510(k) K994328 ยท FTL Mesh, Surgical, Polymeric
SEPRAMESH BIOSURGICAL COMPOSITE, MODEL SMBC-XXX
| Applicant | Genzyme Corp., Cambridge MA, US |
| Decision | Substantially Equivalent, Mar 2, 2000 |
| Received | Dec 22, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K994328
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.