Elcam Stopcocks And Manifolds

Stopcock, I.v. Set

Elcam Medical ACAL

The following data is part of a premarket notification filed by Elcam Medical Acal with the FDA for Elcam Stopcocks And Manifolds.

Pre-market Notification Details

Device IDK190489
510k NumberK190489
Device Name:Elcam Stopcocks And Manifolds
ClassificationStopcock, I.v. Set
Applicant Elcam Medical ACAL Kibbutz Baram Kibbutz Baram,  IL 1386000
ContactAvital Levertov
CorrespondentAvital Levertov
Elcam Medical ACAL Kibbutz Baram Kibbutz Baram,  IL 1386000
Product CodeFMG  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-28
Decision Date2019-04-23

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