510(k) K191067 ยท FED Endoscopic Access Overtube, Gastroenterology-Urology
Arc Endocuff Glide AEG110 & AEG120
| Applicant | Boddingtons Plastics, Ltd., Tonbridge, GB |
| Decision | Substantially Equivalent, May 30, 2019 |
| Received | Apr 22, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K191067
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.