The following data is part of a premarket notification filed by Covidien with the FDA for Kangaroo Connect Enteral Feeding Pump With Kangaroo Connect Feeding Sets.
Device ID | K143263 |
510k Number | K143263 |
Device Name: | Kangaroo Connect Enteral Feeding Pump With Kangaroo Connect Feeding Sets |
Classification | Pump, Infusion, Enteral |
Applicant | COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
Contact | Karin Desjardins |
Correspondent | Karin Desjardins 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 | 2014-11-13 |
Decision Date | 2015-05-29 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10884521190917 | K143263 | 000 |