Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K933200 |
Device Name |
OLYMPUS PBD STENTS |
Applicant |
OLYMPUS CORP. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042
|
|
Applicant Contact |
BARRY E SANDS |
Correspondent |
OLYMPUS CORP. |
4 NEVADA DR. |
LAKE SUCCESS,
NY
11042
|
|
Correspondent Contact |
BARRY E SANDS |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 07/01/1993 |
Decision Date | 04/05/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|