510(k) K162205 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Arc EndoCuff and Arc EndoCuff Vision
| Applicant | Boddingtons Plastics, Ltd., Tonbridge, GB |
| Decision | Substantially Equivalent, Dec 9, 2016 |
| Received | Aug 5, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162205
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.