WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER

Catheter, Straight

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 Pvc Hydrophilic Urethral Catheter.

Pre-market Notification Details

Device IDK133615
510k NumberK133615
Device Name:WELL LEAD PVC HYDROPHILIC URETHRAL CATHETER
ClassificationCatheter, Straight
Applicant WELL LEAD MEDICAL CO. LTD 445 APOLLO BEACH BLVD. Apollo Beach,  FL  33572
ContactJohn Obrien
CorrespondentJohn Obrien
WELL LEAD MEDICAL CO. LTD 445 APOLLO BEACH BLVD. Apollo Beach,  FL  33572
Product CodeEZD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-25
Decision Date2014-02-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
40888277324603 K133615 000
40888277324580 K133615 000
40888277324566 K133615 000
40888277324542 K133615 000
40888277324528 K133615 000

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