COUDE/ OR TIEMANN

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 Coude/ Or Tiemann.

Pre-market Notification Details

Device IDK103371
510k NumberK103371
Device Name:COUDE/ OR TIEMANN
ClassificationCatheter, Retention Type, Balloon
Applicant DEGANIA SILICONE, LTD. DEGANIA BET Emek Hayarden,  IL 15130
ContactZoya Lee
CorrespondentZoya Lee
DEGANIA SILICONE, LTD. DEGANIA BET Emek Hayarden,  IL 15130
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-11-17
Decision Date2011-03-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.