The following data is part of a premarket notification filed by Gi Scientific Llc with the FDA for Gis Endoscopic Optical Lens.
| Device ID | K140295 |
| 510k Number | K140295 |
| Device Name: | GIS ENDOSCOPIC OPTICAL LENS |
| Classification | Gastroscope And Accessories, Flexible/rigid |
| Applicant | GI SCIENTIFIC LLC 128 Blye HIll Landing Newbury, NH 03255 |
| Contact | Michele Lucey |
| Correspondent | Michele Lucey GI SCIENTIFIC LLC 128 Blye HIll Landing Newbury, NH 03255 |
| Product Code | FDS |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-06 |
| Decision Date | 2014-07-24 |