510(k) K963354 ยท ODF Mini Endoscope, Gastroenterology-Urology
5 STAR MEDICAL ENDOSCOPE
| Applicant | Five Star Medical, Inc., Charlottesville VA, US |
| Decision | Substantially Equivalent, Sep 8, 1997 |
| Received | Aug 26, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963354
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.