Device Classification Name |
Colonoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K091783 |
Device Name |
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM |
Applicant |
AVANTIS MEDICAL SYSTEMS, INC. |
263 SANTA ANA CT. |
SUNNYVALE,
CA
94085
|
|
Applicant Contact |
AMRITA SETHI |
Correspondent |
AVANTIS MEDICAL SYSTEMS, INC. |
263 SANTA ANA CT. |
SUNNYVALE,
CA
94085
|
|
Correspondent Contact |
AMRITA SETHI |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/17/2009 |
Decision Date | 07/07/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|