NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS

Set, Administration, Intravascular

CARDIOMED SUPPLIES, INC.

The following data is part of a premarket notification filed by Cardiomed Supplies, Inc. with the FDA for Noncor Infusion Sets; Noncor Port Infusion Sets.

Pre-market Notification Details

Device IDK021080
510k NumberK021080
Device Name:NONCOR INFUSION SETS; NONCOR PORT INFUSION SETS
ClassificationSet, Administration, Intravascular
Applicant CARDIOMED SUPPLIES, INC. 5 GORMLEY INDUSTRIAL AVENUE Gormley, Ontario,  CA L0h 1g0
ContactDonna Mccomb
CorrespondentDonna Mccomb
CARDIOMED SUPPLIES, INC. 5 GORMLEY INDUSTRIAL AVENUE Gormley, Ontario,  CA L0h 1g0
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-04-03
Decision Date2002-08-29

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