510(k) K954231 ยท FCG Biopsy Needle
AUGASTROENTEROLOGY-UROLOGY BIOPSY INSTRUMENT
| Applicant | Promex, Inc., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 22, 1995 |
| Received | Sep 11, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954231
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.