INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,

Set, I.v. Fluid Transfer

CARMEL PHARMA AB.

The following data is part of a premarket notification filed by Carmel Pharma Ab. with the FDA for Injector Luer, Model N34, Injector Luer Lock, Model N35, Injector Luer Lock, N35c, Connector Luer Lock, Model C35,.

Pre-market Notification Details

Device IDK092782
510k NumberK092782
Device Name:INJECTOR LUER, MODEL N34, INJECTOR LUER LOCK, MODEL N35, INJECTOR LUER LOCK, N35C, CONNECTOR LUER LOCK, MODEL C35,
ClassificationSet, I.v. Fluid Transfer
Applicant CARMEL PHARMA AB. AMINOGATAN 30 Molndal,  SE S431 53
ContactKjell Andreasson
CorrespondentKjell Andreasson
CARMEL PHARMA AB. AMINOGATAN 30 Molndal,  SE S431 53
Product CodeLHI  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-10
Decision Date2009-12-07
Summary:summary

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