The following data is part of a premarket notification filed by Avantis Medical Systems, Inc. with the FDA for Third Eye Retroscope Auxiliary Endoscope System.
Device ID | K091783 |
510k Number | K091783 |
Device Name: | THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE 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 | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-06-17 |
Decision Date | 2009-07-07 |
Summary: | summary |