PEDIATRIC FEEDING TUBE

Tubes, Gastrointestinal (and Accessories)

PROMEDIC, INC.

The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Pediatric Feeding Tube.

Pre-market Notification Details

Device IDK052903
510k NumberK052903
Device Name:PEDIATRIC FEEDING TUBE
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville,  IN  46055 -9501
ContactPaul Dryden
CorrespondentPaul Dryden
PROMEDIC, INC. 6329 WEST WATERVIEW CT. Mccordsville,  IN  46055 -9501
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-14
Decision Date2005-11-09
Summary:summary

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