The following data is part of a premarket notification filed by Covidien with the FDA for Kangaroo Enteral Feeding Tube Extension Set With Enfit Small Bore Connectors.
Device ID | K143018 |
510k Number | K143018 |
Device Name: | Kangaroo Enteral Feeding Tube Extension Set With ENFit Small Bore Connectors |
Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
Applicant | Covidien 15 Hampshire Street Mansfeild, MA 02048 |
Contact | Wei Zhao |
Correspondent | Wei Zhao Covidien 15 Hampshire Street Mansfeild, MA 02048 |
Product Code | PIF |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-10-20 |
Decision Date | 2015-04-02 |
Summary: | summary |