Device Classification Name |
choledochoscope and accessories, flexible/rigid
|
510(k) Number |
K904799 |
Device Name |
CHF-B20 CHOLEDOCHOSCOPE |
Applicant |
OLYMPUS CORP. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042
|
|
Applicant Contact |
DANIEL J DILLON |
Correspondent |
OLYMPUS CORP. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042
|
|
Correspondent Contact |
DANIEL J DILLON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/24/1990 |
Decision Date | 03/27/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|