510(k) K080317 ยท FDF Colonoscope And Accessories, Flexible/Rigid
ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL
| Applicant | Syntheon, LLC, Miami FL, US |
| Decision | Substantially Equivalent, Apr 29, 2008 |
| Received | Feb 6, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080317
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.