The following data is part of a premarket notification filed by Exco, Inc. with the FDA for Enteral Nutrition 1.
Device ID | K822879 |
510k Number | K822879 |
Device Name: | ENTERAL NUTRITION 1 |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | EXCO, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-09-27 |
Decision Date | 1982-11-16 |