Device Classification Name |
Endoscopic Cytology Brush
|
510(k) Number |
K192908 |
Device Name |
Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes |
Applicant |
Wilson-Cook Medical, Inc |
4900 Bethania Station Road |
Winston-Salem,
NC
27105
|
|
Applicant Contact |
Tiffanny A. Thomas |
Correspondent |
Wilson-Cook Medical, Inc |
4900 Bethania Station Road |
Winston-Salem,
NC
27105
|
|
Correspondent Contact |
Tiffanny A. Thomas |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/15/2019 |
Decision Date | 11/14/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|