MINIMED PARADIGM INSULIN PUMP, MODEL 511

Pump, Infusion

MINIMED, INC.

The following data is part of a premarket notification filed by Minimed, Inc. with the FDA for Minimed Paradigm Insulin Pump, Model 511.

Pre-market Notification Details

Device IDK001829
510k NumberK001829
Device Name:MINIMED PARADIGM INSULIN PUMP, MODEL 511
ClassificationPump, Infusion
Applicant MINIMED, INC. 12744 SAN FERNANDO RD. Sylmar,  CA  91342
ContactJennifer Lyons
CorrespondentJennifer Lyons
MINIMED, INC. 12744 SAN FERNANDO RD. Sylmar,  CA  91342
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-06-16
Decision Date2000-08-18

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