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, Kangaroo Connect Portal.
| Device ID | K153074 |
| 510k Number | K153074 |
| Device Name: | Kangaroo Connect Enteral Feeding Pump With Kangaroo Connect Feeding Sets, Kangaroo Connect Portal |
| Classification | Pump, Infusion, Enteral |
| Applicant | COVIDIEN 15 HAMPSHIRE STREET Mansfiled, MA 02048 |
| Contact | Karin Desjardins |
| Correspondent | Karin Desjardins COVIDIEN 15 HAMPSHIRE STREET Mansfiled, 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 | 2015-10-22 |
| Decision Date | 2016-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885380166004 | K153074 | 000 |