Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K912122 |
Device Name |
CHOLANGIOGRAPHY CATHETER |
Applicant |
WILTEK MEDICAL, INC. |
P.O.BOX 11946 |
WINSTON-SALEM,
NC
27116
|
|
Applicant Contact |
JON S WILSON |
Correspondent |
WILTEK MEDICAL, INC. |
P.O.BOX 11946 |
WINSTON-SALEM,
NC
27116
|
|
Correspondent Contact |
JON S WILSON |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 05/14/1991 |
Decision Date | 09/23/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|