510(k) K102616 ยท FDF Colonoscope And Accessories, Flexible/Rigid
NAVIAID BALLOON GUIDED COLONOSCOPY (BGC) DEVICE
| Applicant | Smart Medical Systems , Ltd., Raanana, IL |
| Decision | Substantially Equivalent, Dec 30, 2010 |
| Received | Sep 10, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102616
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.