The following data is part of a premarket notification filed by Medcaptain Life Science Co., Ltd. with the FDA for Enteral Feeding Catheter.
Device ID | K202748 |
510k Number | K202748 |
Device Name: | Enteral Feeding Catheter |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | Medcaptain Life Science Co., Ltd. 601, Building C, Jinweiyuan Industrial Park, Pingshan Distri Shenzhen, CN 518118 |
Contact | David Xia |
Correspondent | David Xia Medcaptain Life Science Co., Ltd. 601, Building C, Jinweiyuan Industrial Park, Pingshan Distri Shenzhen, CN 518118 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-09-21 |
Decision Date | 2021-04-09 |