Device Classification Name |
endoscopic traction device
|
510(k) Number |
K222354 |
Device Name |
Elastic Traction System |
Applicant |
Micro-Tech (Nanjing) Co., Ltd. |
No.10 Gaoke Third Road, Nanjing National |
Hi-Tech Industrial Development Zone |
Nanjing,
CN
210032
|
|
Applicant Contact |
Sally He |
Correspondent |
Micro-Tech (Nanjing) Co., Ltd. |
No.10 Gaoke Third Road, Nanjing National |
Hi-Tech Industrial Development Zone |
Nanjing,
CN
210032
|
|
Correspondent Contact |
Sally He |
Regulation Number | 876.4410
|
Classification Product Code |
|
Date Received | 08/04/2022 |
Decision Date | 10/03/2022 |
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
|
|
|