Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K903420 |
Device Name |
SOEHENDRA STENT RETRIEVER |
Applicant |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. & |
5951 GRASSY CREEK BLVD. |
WINSTON-SALEM,
NC
27105
|
|
Applicant Contact |
RICHARD MARSHALL |
Correspondent |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. & |
5951 GRASSY CREEK BLVD. |
WINSTON-SALEM,
NC
27105
|
|
Correspondent Contact |
RICHARD MARSHALL |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 07/31/1990 |
Decision Date | 10/22/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|