The following data is part of a premarket notification filed by Covidien with the FDA for Kangaroo Feeding Tubes With Iris Technology.
| Device ID | K123555 |
| 510k Number | K123555 |
| Device Name: | KANGAROO FEEDING TUBES WITH IRIS TECHNOLOGY |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Contact | Jim Welsh |
| Correspondent | Jim Welsh COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-19 |
| Decision Date | 2014-04-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521742239 | K123555 | 000 |
| 10884521706156 | K123555 | 000 |
| 10884521706149 | K123555 | 000 |
| 10884521706132 | K123555 | 000 |
| 10884521706125 | K123555 | 000 |
| 10884521706118 | K123555 | 000 |
| 10884521706101 | K123555 | 000 |
| 10884521706095 | K123555 | 000 |
| 10884521706088 | K123555 | 000 |
| 10884521706163 | K123555 | 000 |
| 10884521706170 | K123555 | 000 |
| 10884521742222 | K123555 | 000 |
| 10884521742215 | K123555 | 000 |
| 10884521742208 | K123555 | 000 |
| 10884521742192 | K123555 | 000 |
| 10884521742185 | K123555 | 000 |
| 10884521742178 | K123555 | 000 |
| 10884521742161 | K123555 | 000 |
| 10884521742154 | K123555 | 000 |
| 10884521165069 | K123555 | 000 |