510(k) K980997 ยท IWJ System, Applicator, Radionuclide, Manual
PGK DEVICE (MODIFIED)
| Applicant | Pgk, Inc., Vienna VA, US |
| Decision | Substantially Equivalent, Sep 28, 1998 |
| Received | Mar 17, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980997
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.