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 |