TEMPERATURE SENSOR CATHETER

Catheter, Retention Type, Balloon

DEGANIA SILICONE, LTD.

The following data is part of a premarket notification filed by Degania Silicone, Ltd. with the FDA for Temperature Sensor Catheter.

Pre-market Notification Details

Device IDK131020
510k NumberK131020
Device Name:TEMPERATURE SENSOR CATHETER
ClassificationCatheter, Retention Type, Balloon
Applicant DEGANIA SILICONE, LTD. KIBBUTZ DEGANIA BET Israel,  IL 15130
ContactZoya Lee
CorrespondentZoya Lee
DEGANIA SILICONE, LTD. KIBBUTZ DEGANIA BET Israel,  IL 15130
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-04-12
Decision Date2013-05-09

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