CORPAK GASTROSTOMY TUBE

Tubes, Gastrointestinal (and Accessories)

CORPAK CO.

The following data is part of a premarket notification filed by Corpak Co. with the FDA for Corpak Gastrostomy Tube.

Pre-market Notification Details

Device IDK931921
510k NumberK931921
Device Name:CORPAK GASTROSTOMY TUBE
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant CORPAK CO. 100 CHADDICK DR. Wheeling,  IL  60090
ContactRobert E Booth
CorrespondentRobert E Booth
CORPAK CO. 100 CHADDICK DR. Wheeling,  IL  60090
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-16
Decision Date1995-06-09

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