CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET

Set, Administration, Intravascular

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Continuflo Solution Set/secondary Medication Set.

Pre-market Notification Details

Device IDK961225
510k NumberK961225
Device Name:CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET
ClassificationSet, Administration, Intravascular
Applicant BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake,  IL  60073
ContactMary Ellen Snyder
CorrespondentMary Ellen Snyder
BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake,  IL  60073
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-03-29
Decision Date1996-06-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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10884389466797 K961225 000

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