LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH.

Pump, Infusion

BAXTER HEALTHCARE CORP.

The following data is part of a premarket notification filed by Baxter Healthcare Corp. with the FDA for Large Volume Elastomeric Infusion Device Attach..

Pre-market Notification Details

Device IDK910425
510k NumberK910425
Device Name:LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH.
ClassificationPump, Infusion
Applicant BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake,  IL  60073
ContactPatricia S Barsanti
CorrespondentPatricia S Barsanti
BAXTER HEALTHCARE CORP. ROUTE 120 AND WILSON RD. Round Lake,  IL  60073
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-31
Decision Date1991-04-01

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