510(k) K080332 ยท ESW Prosthesis, Esophageal
POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Sep 5, 2008 |
| Received | Feb 7, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080332
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.