ARTERIAL BLOOD SAMPLING KIT

Catheter, Intravascular, Diagnostic

MEDEX, INC.

The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Arterial Blood Sampling Kit.

Pre-market Notification Details

Device IDK902771
510k NumberK902771
Device Name:ARTERIAL BLOOD SAMPLING KIT
ClassificationCatheter, Intravascular, Diagnostic
Applicant MEDEX, INC. 3637 LACON RD. Hillard,  OH  43026
ContactCathy Chenetski
CorrespondentCathy Chenetski
MEDEX, INC. 3637 LACON RD. Hillard,  OH  43026
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-21
Decision Date1990-11-05

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