NON-IV ADAPTER FOR INFANT NG TUBE

Tubes, Gastrointestinal (and Accessories)

PROMEDIC, INC.

The following data is part of a premarket notification filed by Promedic, Inc. with the FDA for Non-iv Adapter For Infant Ng Tube.

Pre-market Notification Details

Device IDK072756
510k NumberK072756
Device Name:NON-IV ADAPTER FOR INFANT NG TUBE
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant PROMEDIC, INC. 3460 POINTE CREEK CT., #102 Bonita Springs,  FL  34134 -2015
ContactPaul Dryden
CorrespondentPaul Dryden
PROMEDIC, INC. 3460 POINTE CREEK CT., #102 Bonita Springs,  FL  34134 -2015
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-09-27
Decision Date2007-12-19
Summary:summary

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