The following data is part of a premarket notification filed by Avanos Medical Inc with the FDA for Avanos* Cortrak* 2 Enteral Access System (eas).
| Device ID | K220588 |
| 510k Number | K220588 |
| Device Name: | Avanos* CORTRAK* 2 Enteral Access System (EAS) |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Avanos Medical Inc 5405 Windward Parkway Alpharetta, GA 30004 |
| Contact | Nikin Desai |
| Correspondent | Angela Cushman Avanos Medical, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-01 |
| Decision Date | 2022-04-22 |