WIJAY EZ-VOID EXTERNAL CATHETER VALVE

Accessories, Catheter, G-u

LEOMED, LLC

The following data is part of a premarket notification filed by Leomed, Llc with the FDA for Wijay Ez-void External Catheter Valve.

Pre-market Notification Details

Device IDK140562
510k NumberK140562
Device Name:WIJAY EZ-VOID EXTERNAL CATHETER VALVE
ClassificationAccessories, Catheter, G-u
Applicant LEOMED, LLC 9001 AIRPORT BLVD SUITE 503 Houston,  TX  77061
ContactBandula Wijay
CorrespondentBandula Wijay
LEOMED, LLC 9001 AIRPORT BLVD SUITE 503 Houston,  TX  77061
Product CodeKNY  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-03-05
Decision Date2014-06-16

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