Device Classification Name |
Endoscopic Cytology Brush
|
510(k) Number |
K040324 |
Device Name |
WILSON-COOK DOUBLE LUMEN BILIARY CYTOLOGY BRUSH |
Applicant |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. |
WINSTON-SALEM,
NC
27105
|
|
Applicant Contact |
MARGE WALLS-WALKER |
Correspondent |
WILSON-COOK MEDICAL, INC. |
4900 BETHANIA STATION RD. |
WINSTON-SALEM,
NC
27105
|
|
Correspondent Contact |
MARGE WALLS-WALKER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/10/2004 |
Decision Date | 05/20/2004 |
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
|
|
|