BLOOD HAND PUMP ADMINISTRATION SET

Set, Blood Transfusion

CARDINAL HEALTH, ALARIS PRODUCTS

The following data is part of a premarket notification filed by Cardinal Health, Alaris Products with the FDA for Blood Hand Pump Administration Set.

Pre-market Notification Details

Device IDK050115
510k NumberK050115
Device Name:BLOOD HAND PUMP ADMINISTRATION SET
ClassificationSet, Blood Transfusion
Applicant CARDINAL HEALTH, ALARIS PRODUCTS 10221 WATERIDGE CIRCLE San Diego,  CA  92121 -2772
ContactStacy L Lewis
CorrespondentStacy L Lewis
CARDINAL HEALTH, ALARIS PRODUCTS 10221 WATERIDGE CIRCLE San Diego,  CA  92121 -2772
Product CodeBRZ  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-01-18
Decision Date2005-04-01
Summary:summary

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