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 |