Device Classification Name |
Stents, Drains And Dilators For The Biliary Ducts
|
510(k) Number |
K101095 |
Device Name |
DIRECT PERORAL CHOLANGIOSCOPY BALLOON |
Applicant |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION ROAD |
WINSTON SALEM,
NC
|
|
Applicant Contact |
SCOTTIE FARIOLE |
Correspondent |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION ROAD |
WINSTON SALEM,
NC
|
|
Correspondent Contact |
SCOTTIE FARIOLE |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 04/20/2010 |
Decision Date | 07/19/2010 |
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
|
|
|