Device Classification Name |
Endoscopic Cytology Brush
|
510(k) Number |
K172663 |
Device Name |
Cytology Brush |
Applicant |
Micro-Tech (Nanjing) CO., Ltd. |
NO. 10 Gaoke Third Road |
Nanjing,
CN
210032
|
|
Applicant Contact |
Becky Li |
Correspondent |
Micro-Tech (Nanjing) CO., Ltd. |
NO. 10 Gaoke Third Road |
Nanjing,
CN
210032
|
|
Correspondent Contact |
Becky Li |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 09/05/2017 |
Decision Date | 03/05/2018 |
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
|
|
|