The following data is part of a premarket notification filed by Covidien with the FDA for Argyle¿ Polyvinyl Chloride (pvc) And Kangaroo¿ Polyurethane (pu) Neonatal And Pediatric Feeding Tubes With Enfit Connector.
| Device ID | K150084 |
| 510k Number | K150084 |
| Device Name: | Argyle¿ Polyvinyl Chloride (PVC) And Kangaroo¿ Polyurethane (PU) Neonatal And Pediatric Feeding Tubes With ENFit Connector |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Contact | Sona Manickam |
| Correspondent | Sona Manickam COVIDIEN 15 HAMPSHIRE STREET Mansfield, 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 | 2015-01-15 |
| Decision Date | 2015-07-13 |
| Summary: | summary |