The following data is part of a premarket notification filed by Boddingtons Plastics Ltd with the FDA for Arc Endocuff And Arc Endocuff Vision.
| Device ID | K162205 |
| 510k Number | K162205 |
| Device Name: | Arc EndoCuff And Arc EndoCuff Vision |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | BODDINGTONS PLASTICS LTD UNIT 6 PATTENDEN LANE, MARDEN Tonbridge, GB Tn12 9qj |
| Contact | Sarah Gibson |
| Correspondent | Sarah Gibson BODDINGTONS PLASTICS LTD UNIT 6 PATTENDEN LANE, MARDEN Tonbridge, GB Tn12 9qj |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-05 |
| Decision Date | 2016-12-09 |
| Summary: | summary |