The following data is part of a premarket notification filed by Covidien with the FDA for Kangaroo Enteral Feeding Set With Enfit Connectors.
Device ID | K141479 |
510k Number | K141479 |
Device Name: | KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS |
Classification | Pump, Infusion, Enteral |
Applicant | COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
Contact | Teghpal Singh |
Correspondent | Teghpal Singh COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
Product Code | LZH |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-06-04 |
Decision Date | 2014-12-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
40884521657602 | K141479 | 000 |