510(k) K093718 ยท FCY Bulb, Inflation, For Endoscope
ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003
| Applicant | Zutron Medical, LLC, Lenexa KS, US |
| Decision | Substantially Equivalent, Feb 22, 2010 |
| Received | Dec 2, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093718
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.