510(k) K203397 ยท KNW Instrument, Biopsy
Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm
| Applicant | Biopsybell S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Jan 11, 2021 |
| Received | Nov 18, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203397
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.