QUICK-SERTER, MODEL 395

Introducer, Syringe Needle

MEDTRONIC MINIMED

The following data is part of a premarket notification filed by Medtronic Minimed with the FDA for Quick-serter, Model 395.

Pre-market Notification Details

Device IDK992300
510k NumberK992300
Device Name:QUICK-SERTER, MODEL 395
ClassificationIntroducer, Syringe Needle
Applicant MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar,  CA  91342
ContactDon Selvey
CorrespondentDon Selvey
MEDTRONIC MINIMED 12744 SAN FERNANDO RD. Sylmar,  CA  91342
Product CodeKZH  
CFR Regulation Number880.6920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-08
Decision Date1999-07-29
Summary:summary

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