Aquarius Stoma Measuring Device

Tubes, Gastrointestinal (and Accessories)

DEGANIA SILICONE LTD

The following data is part of a premarket notification filed by Degania Silicone Ltd with the FDA for Aquarius Stoma Measuring Device.

Pre-market Notification Details

Device IDK152246
510k NumberK152246
Device Name:Aquarius Stoma Measuring Device
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant DEGANIA SILICONE LTD Degania Bet,  IL 1513000
ContactZoya Lee
CorrespondentZoya Lee
DEGANIA SILICONE LTD Degania Bet,  IL 1513000
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-08-10
Decision Date2016-06-21
Summary:summary

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