ALL-IN-ONE CONTAINER

Container, I.v.

BAXTER HEALTHCARE CORPORATION

The following data is part of a premarket notification filed by Baxter Healthcare Corporation with the FDA for All-in-one Container.

Pre-market Notification Details

Device IDK090096
510k NumberK090096
Device Name:ALL-IN-ONE CONTAINER
ClassificationContainer, I.v.
Applicant BAXTER HEALTHCARE CORPORATION 1620 WAUKEGAN ROAD Mcgaw Park,  IL  60085
ContactNanette Hedden
CorrespondentNed Devine
UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook,  IL  60062
Product CodeKPE  
CFR Regulation Number880.5025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-01-15
Decision Date2009-01-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50085412043864 K090096 000
50085412042126 K090096 000
50085412041419 K090096 000

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