BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE

Needle, Hypodermic, Single Lumen

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Baxter Disposable Intraosseous Infusion Needle.

Pre-market Notification Details

Device IDK930217
510k NumberK930217
Device Name:BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE
ClassificationNeedle, Hypodermic, Single Lumen
Applicant BAXTER HEALTHCARE CORP. 27200 NORTH TOURNEY RD. P.O. BOX 5900 Valencia,  CA  91355 -8900
ContactJan Robertson
CorrespondentJan Robertson
BAXTER HEALTHCARE CORP. 27200 NORTH TOURNEY RD. P.O. BOX 5900 Valencia,  CA  91355 -8900
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-15
Decision Date1994-02-28

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