Device Classification Name |
duodenoscope and accessories, flexible/rigid
|
510(k) Number |
K080403 |
FOIA Releasable 510(k) |
K080403
|
Device Name |
XTJF TYPE Q160VF1 |
Applicant |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Applicant Contact |
LAURA STORM-TYLER |
Correspondent |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
3500 CORPORATE PARKWAY |
PO BOX 610 |
CENTER VALLEY,
PA
18034 -0610
|
|
Correspondent Contact |
LAURA STORM-TYLER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/14/2008 |
Decision Date | 05/20/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|