510(k) K082705 ยท KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
BIOPRO BIPOLAR HEAD, MODELS 18130-18152
| Applicant | Biopro, Inc., Port Huron MI, US |
| Decision | Substantially Equivalent, Dec 15, 2008 |
| Received | Sep 16, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082705
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.