The following data is part of a premarket notification filed by Cardinal Health with the FDA for Salem Sump Silicone Dual Lumen Stomach Tube With Enfit Connection.
| Device ID | K213174 |
| 510k Number | K213174 |
| Device Name: | Salem Sump Silicone Dual Lumen Stomach Tube With ENFit Connection |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | Cardinal Health 3651 Birchwood Drive Waukegan, IL 60085 |
| Contact | Nivedita Namjoshi |
| Correspondent | Nivedita Namjoshi Cardinal Health 3651 Birchwood Drive Waukegan, IL 60085 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-28 |
| Decision Date | 2022-05-19 |