The following data is part of a premarket notification filed by Boddingtons Plastics Ltd with the FDA for Arc Endocuff Vision.
| Device ID | K151801 |
| 510k Number | K151801 |
| Device Name: | Arc Endocuff Vision |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | BODDINGTONS PLASTICS LTD WHEELBARROW PARK ESTATE PATTENDEN LANE, MARDEN Tonbridge, GB Tn12 9ql |
| Contact | Paul Blackmore |
| Correspondent | Paul Blackmore BODDINGTONS PLASTICS LTD WHEELBARROW PARK ESTATE PATTENDEN LANE, MARDEN Tonbridge, GB Tn12 9ql |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-02 |
| Decision Date | 2015-08-13 |