510(k) K972328 ยท KNW Instrument, Biopsy
PERCUTANEOUS BREAST BIOPSY (PBB)
| Applicant | Urothealth System, Inc., Richland MI, US |
| Decision | Substantially Equivalent, Jul 7, 1998 |
| Received | Jun 23, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972328
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.