|
Device |
endoscopic cytology brush |
Definition |
To collect cells for cytological evaluation. |
Product Code | FDX |
Regulation Number |
876.1500
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
COOK INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MICRO-TECH (NANJING) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
UNITED STATES ENDOSCOPY GROUP, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WILSON-COOK MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K171573 Fusion Cytology Brush, CytoMax II Double Lumen Cyt ...
|
2. K181317 Fusion Cytology Brush, CytoMax II Double Lumen Cyt ...
|
WILSON-COOK MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
1. K171573 Fusion Cytology Brush, CytoMax II Double Lumen Cyt ...
|
2. K181317 Fusion Cytology Brush, CytoMax II Double Lumen Cyt ...
|
WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|