SafePort(TM) Manifold (or Stopcock)

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 Safeport(tm) Manifold (or Stopcock).

Pre-market Notification Details

Device IDK211204
510k NumberK211204
Device Name:SafePort(TM) Manifold (or Stopcock)
ClassificationStopcock, I.v. Set
Applicant Elcam Medical ACAL Kibbutz Baram Kibbutz Baram,  IL 1386000
ContactAvital Levertov
CorrespondentTali Hazan
Elcam Medical ACAL Ramot-Naftali M.P Upper Galilee,  IL 1383000
Product CodeFMG  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-22
Decision Date2022-09-15

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