Device Classification Name |
duodenoscope and accessories, flexible/rigid
|
510(k) Number |
K024033 |
Device Name |
XTJF-160AF DUODENOVIDEOSCOPE |
Applicant |
OLYMPUS OPTICAL CO., LTD. |
TWO CORPORATE CENTER DR. |
MELVILLE,
NY
11747 -3157
|
|
Applicant Contact |
LAURA STORMS-TYLER |
Correspondent |
INTERTEK TESTING SERVICES |
2307 EAST AURORA ROAD |
UNIT B7 |
TWINSBURG,
OH
44087
|
|
Correspondent Contact |
DONALD J SHERRATT |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 12/06/2002 |
Decision Date | 12/20/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|