WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR

Catheter, Retention Type, Balloon

WELL LEAD MEDICAL CO. LTD

The following data is part of a premarket notification filed by Well Lead Medical Co. Ltd with the FDA for Well Lead Silicone Catheter With Temperature Sensor.

Pre-market Notification Details

Device IDK091516
510k NumberK091516
Device Name:WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR
ClassificationCatheter, Retention Type, Balloon
Applicant WELL LEAD MEDICAL CO. LTD 962 ALLEGRO LANE Apollo Beach,  FL  33572
ContactArthur Ward
CorrespondentArthur Ward
WELL LEAD MEDICAL CO. LTD 962 ALLEGRO LANE Apollo Beach,  FL  33572
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-22
Decision Date2009-10-16
Summary:summary

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