The following data is part of a premarket notification filed by Viasys Medsystems with the FDA for Modification To Cortrak Enteral Access Device, Model 20-0900.
| Device ID | K080679 |
| 510k Number | K080679 |
| Device Name: | MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | VIASYS MEDSYSTEMS 100 CHADDICK DR. Wheeling, IL 60090 |
| Contact | Stephanie Wasielewski |
| Correspondent | Stephanie Wasielewski VIASYS MEDSYSTEMS 100 CHADDICK DR. Wheeling, IL 60090 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-10 |
| Decision Date | 2008-06-27 |