MODIFICATION TO PLUM XL INFUSION PUMP

Pump, Infusion

ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Modification To Plum Xl Infusion Pump.

Pre-market Notification Details

Device IDK010924
510k NumberK010924
Device Name:MODIFICATION TO PLUM XL INFUSION PUMP
ClassificationPump, Infusion
Applicant ABBOTT LABORATORIES DEPT.37K, BUILDING AP30 200 ABBOTT PARK ROAD Abbott Park,  IL  60064 -6157
ContactFrank Pokrop
CorrespondentFrank Pokrop
ABBOTT LABORATORIES DEPT.37K, BUILDING AP30 200 ABBOTT PARK ROAD Abbott Park,  IL  60064 -6157
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-27
Decision Date2001-04-06

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