THE CHICAGO GULLET

Tubes, Gastrointestinal (and Accessories)

UNIVERSAL PROSTHETICS, INC.

The following data is part of a premarket notification filed by Universal Prosthetics, Inc. with the FDA for The Chicago Gullet.

Pre-market Notification Details

Device IDK813132
510k NumberK813132
Device Name:THE CHICAGO GULLET
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant UNIVERSAL PROSTHETICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-11-05
Decision Date1982-01-07

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