510(k) K962154 ยท DTJ Holder, Heart-Valve, Prosthesis
CARBOMEDICS HANDLE
| Applicant | Carbomedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Aug 27, 1996 |
| Received | Jun 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962154
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.