510(k) K981301 ยท KNW Instrument, Biopsy
SPEED-CUT AUTOMATIC BIOPSY SYSTEM
| Applicant | Gallini U.S., LLC, Richmond VA, US |
| Decision | Substantially Equivalent, Jul 8, 1998 |
| Received | Apr 9, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981301
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.