0.9% SODIUM CHLORIDE FLUSH SYRINGE

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for 0.9% Sodium Chloride Flush Syringe.

Pre-market Notification Details

Device IDK984590
510k NumberK984590
Device Name:0.9% SODIUM CHLORIDE FLUSH SYRINGE
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake,  IL  60073
ContactMarcia Marconi
CorrespondentMarcia Marconi
BAXTER HEALTHCARE CORP. RT. 120 & WILSON RD. Round Lake,  IL  60073
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-12-28
Decision Date1999-10-07
Summary:summary

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