The following data is part of a premarket notification filed by Covidien with the FDA for Salem Sump Dual Lumen Stomach Tube With Multi-functional Port.
| Device ID | K150711 |
| 510k Number | K150711 |
| Device Name: | Salem Sump Dual Lumen Stomach Tube With Multi-functional Port |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | COVIDIEN 15 HAMPSHIRE STREET Mansfiled, MA 02048 |
| Contact | Jim Welsh |
| Correspondent | Wei Zhao COVIDIEN 15 HAMPSHIRE STREET Mansfiled, 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 | 2015-03-19 |
| Decision Date | 2015-10-08 |
| Summary: | summary |