The following data is part of a premarket notification filed by Boddingtons Plastics Ltd with the FDA for Arc Endocuff Glide Aeg110 & Aeg120.
| Device ID | K191067 |
| 510k Number | K191067 |
| Device Name: | Arc Endocuff Glide AEG110 & AEG120 |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | Boddingtons Plastics Ltd Wheelbarrow Park Estate, Pattenden Lane, Marden Tonbridge, GB Tn12 9qj |
| Contact | Shimaa Elsawy |
| Correspondent | Shimaa Elsawy Boddingtons Plastics Ltd Wheelbarrow Park Estate, Pattenden Lane, Marden Tonbridge, GB Tn12 9qj |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-22 |
| Decision Date | 2019-05-30 |