510(k) K091962 ยท ODF Mini Endoscope, Gastroenterology-Urology
POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200
| Applicant | Lumenis, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Sep 30, 2009 |
| Received | Jul 1, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091962
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.