510(k) K983621 ยท IZH System, X-Ray, Mammographic
NEEDLE GUIDE
| Applicant | Remington Medical, Inc., Alpharetta GA, US |
| Decision | Substantially Equivalent, Nov 3, 1998 |
| Received | Oct 15, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983621
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.