GASTROSTOMY REPLACEMENT TUBE, MODEL 253

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 Gastrostomy Replacement Tube, Model 253.

Pre-market Notification Details

Device IDK070124
510k NumberK070124
Device Name:GASTROSTOMY REPLACEMENT TUBE, MODEL 253
ClassificationTubes, Gastrointestinal (and Accessories)
Applicant DEGANIA SILICONE, LTD. DEGANIA BET Emek Hayarden,  IL 15130
ContactZoya Lee
CorrespondentZoya Lee
DEGANIA SILICONE, LTD. DEGANIA BET Emek Hayarden,  IL 15130
Product CodeKNT  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-16
Decision Date2007-05-23

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