The following data is part of a premarket notification filed by Avantis Medical Systems, Inc. with the FDA for Third Eye Retroscope Auxiliary Endoscopy System.
| Device ID | K083180 |
| 510k Number | K083180 |
| Device Name: | THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM |
| Classification | Colonoscope And Accessories, Flexible/rigid |
| Applicant | AVANTIS MEDICAL SYSTEMS, INC. 263 SANTA ANA CT. Sunnyvale, CA 94085 |
| Contact | Amrita Sethi |
| Correspondent | Amrita Sethi AVANTIS MEDICAL SYSTEMS, INC. 263 SANTA ANA CT. Sunnyvale, CA 94085 |
| Product Code | FDF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-28 |
| Decision Date | 2009-02-12 |
| Summary: | summary |