510(k) K913815 ยท DWO Needle, Biopsy, Cardiovascular
AUTOMATED BIOPSY DEVICE, MODIFICATION
| Applicant | Hart Enterprises, Inc., Wyoming MI, US |
| Decision | Substantially Equivalent, Oct 30, 1991 |
| Received | Aug 26, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913815
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.