Device Classification Name |
Gastroscope And Accessories, Flexible/Rigid
|
510(k) Number |
K001766 |
Device Name |
OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE |
Applicant |
OLYMPUS OPTICAL CO., LTD. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Applicant Contact |
LAURA STORMS-TAYLOR |
Correspondent |
OLYMPUS OPTICAL CO., LTD. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Correspondent Contact |
LAURA STORMS-TAYLOR |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/12/2000 |
Decision Date | 09/08/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|