FLEXIFLO ENTERAL FEEDING TUBE

Tubes, Gastrointestinal (and Accessories)

ROSS PRODUCT DIV. ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Ross Product Div. Abbott Laboratories with the FDA for Flexiflo Enteral Feeding Tube.

Pre-market Notification Details

Device IDK992494
510k NumberK992494
Device Name:FLEXIFLO ENTERAL FEEDING TUBE
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant ROSS PRODUCT DIV. ABBOTT LABORATORIES 625 CLEVELAND AVENUE Columbus,  OH  43215
ContactDaniel Hamilton
CorrespondentDaniel Hamilton
ROSS PRODUCT DIV. ABBOTT LABORATORIES 625 CLEVELAND AVENUE Columbus,  OH  43215
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-26
Decision Date1999-08-25

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