510(k) K974158 ยท KNW Instrument, Biopsy
ORION MEDICAL INC. DISPOSABLE BRAIN BIOPSY NEEDLE FOR STEROTACTIC GUIDED BIOPSY
| Applicant | Ortho Development Corp., Draper UT, US |
| Decision | Substantially Equivalent, Dec 9, 1997 |
| Received | Nov 3, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974158
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.