510(k) K915634 ยท EKX Handpiece, Direct Drive, Ac-Powered
FRESENIUS PD+ EXCHANGE DEVICE
| Applicant | Fresenius USA, Inc., Concord CA, US |
| Decision | Substantially Equivalent, Jul 1, 1993 |
| Received | Dec 17, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915634
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.