ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS

Set, Administration, Intravascular

ALARIS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Alaris Medical Systems, Inc. with the FDA for Alaris Medical Infusion System Administration Sets.

Pre-market Notification Details

Device IDK022209
510k NumberK022209
Device Name:ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
ClassificationSet, Administration, Intravascular
Applicant ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. San Diego,  CA  92121
ContactRenne L Fluet
CorrespondentRenne L Fluet
ALARIS MEDICAL SYSTEMS, INC. 10221 WATERIDGE CIR. San Diego,  CA  92121
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-08
Decision Date2002-08-06
Summary:summary

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