510(k) K973152 ยท KNW Instrument, Biopsy
GALLINI ABS DEVICE
| Applicant | Gallini U.S., LLC, Glen Allen VA, US |
| Decision | Substantially Equivalent, Jan 9, 1998 |
| Received | Aug 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973152
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.