Device Classification Name |
endoscopic cytology brush
|
510(k) Number |
K171607 |
Device Name |
Bronchi and Gastrointestinal Cytology Brush |
Applicant |
Wilson-Cook Medical, Inc. / Cook Endoscopy |
4900 Bethania Station Road |
Winston-Salem,
NC
27105
|
|
Applicant Contact |
Doris A. Hawks |
Correspondent |
Wilson-Cook Medical, Inc. / Cook Endoscopy |
4900 Bethania Station Road |
Winston-Salem,
NC
27105
|
|
Correspondent Contact |
Doris A. Hawks |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/01/2017 |
Decision Date | 07/31/2017 |
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
|
|
|