The following data is part of a premarket notification filed by Avanos Medical, Inc. with the FDA for Cortrak* 2 Equilateral Enteral Access System.
| Device ID | K191340 |
| 510k Number | K191340 |
| Device Name: | CORTRAK* 2 Equilateral Enteral Access System |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | Avanos Medical, Inc. 5405 Windward Parkway Alpharetta, GA 30004 |
| Contact | Monica King |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-05-20 |
| Decision Date | 2019-06-04 |