The following data is part of a premarket notification filed by Avantis Medical Systems, Inc. with the FDA for Third Eye Panoramic Auxiliary Endoscopy System - Resposable.
| Device ID | K160356 |
| 510k Number | K160356 |
| Device Name: | Third Eye Panoramic Auxiliary Endoscopy System - Resposable |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | AVANTIS MEDICAL SYSTEMS, INC. 2367 BERING DRIVE San Jose, CA 95131 |
| Contact | Louis Fries |
| Correspondent | Louis Fries AVANTIS MEDICAL SYSTEMS, INC. 2367 BERING DRIVE San Jose, CA 95131 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-08 |
| Decision Date | 2016-05-17 |
| Summary: | summary |