MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385

Introducer, Syringe Needle

MINIMED, INC.

The following data is part of a premarket notification filed by Minimed, Inc. with the FDA for Mimimed Sil-serter Infusion Set Insertion System, Model 385.

Pre-market Notification Details

Device IDK010377
510k NumberK010377
Device Name:MIMIMED SIL-SERTER INFUSION SET INSERTION SYSTEM, MODEL 385
ClassificationIntroducer, Syringe Needle
Applicant MINIMED, INC. 18000 DEVONSHIRE ST. Northridge,  CA  91325
ContactJennifer Lyons
CorrespondentJennifer Lyons
MINIMED, INC. 18000 DEVONSHIRE ST. Northridge,  CA  91325
Product CodeKZH  
CFR Regulation Number880.6920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-02-08
Decision Date2001-04-05

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00763000381080 K010377 000

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