Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K202748 |
Device Name |
Enteral Feeding Catheter |
Applicant |
Medcaptain Life Science Co., Ltd. |
601, Building C, Jinweiyuan Industrial Park, Pingshan Distri |
Shenzhen,
CN
518118
|
|
Applicant Contact |
David Xia |
Correspondent |
Medcaptain Life Science Co., Ltd. |
601, Building C, Jinweiyuan Industrial Park, Pingshan Distri |
Shenzhen,
CN
518118
|
|
Correspondent Contact |
David Xia |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 09/21/2020 |
Decision Date | 04/09/2021 |
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
|
|
|