The following data is part of a premarket notification filed by Codan Us Corp. with the FDA for Codan Safefeed Enteral Feeding Reservoir.
| Device ID | K112268 |
| 510k Number | K112268 |
| Device Name: | CODAN SAFEFEED ENTERAL FEEDING RESERVOIR |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | CODAN US CORP. 3511 WEST SUNFLOWER AVE. Santa Ana, CA 92704 -6944 |
| Contact | Jeff Nielsen |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-08-08 |
| Decision Date | 2012-03-19 |