The following data is part of a premarket notification filed by Universal Prosthetics, Inc. with the FDA for The Chicago Gullet.
Device ID | K813132 |
510k Number | K813132 |
Device Name: | THE CHICAGO GULLET |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | UNIVERSAL PROSTHETICS, 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 | 1981-11-05 |
Decision Date | 1982-01-07 |