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 IDK133129
510k NumberK133129
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 (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-09-30
Decision Date2014-06-19
Summary:summary

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