AbbVie NJ

Tubes, Gastrointestinal (and Accessories)

ABBVIE INC.

The following data is part of a premarket notification filed by Abbvie Inc. with the FDA for Abbvie Nj.

Pre-market Notification Details

Device IDK142792
510k NumberK142792
Device Name:AbbVie NJ
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant ABBVIE INC. 1 N. WAUKEGAN RD. North Chicago,  IL  60064
ContactKatherine Wortley
CorrespondentKatherine Wortley
ABBVIE INC. 1 N. WAUKEGAN RD. North Chicago,  IL  60064
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2014-09-26
Decision Date2015-01-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
38054083008302 K142792 000

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