NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')

Needle, Hypodermic, Single Lumen

NOVO NORDISK INC.

The following data is part of a premarket notification filed by Novo Nordisk Inc. with the FDA for Novotwist Needle, Models 30g * 8mm (1/3) 32 G Tip * 5 Mm(1/5').

Pre-market Notification Details

Device IDK093109
510k NumberK093109
Device Name:NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')
ClassificationNeedle, Hypodermic, Single Lumen
Applicant NOVO NORDISK INC. 100 COLLEGE ROAD WEST Princeton,  NJ  08540 -7810
ContactCindy Cao
CorrespondentCindy Cao
NOVO NORDISK INC. 100 COLLEGE ROAD WEST Princeton,  NJ  08540 -7810
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-10-01
Decision Date2010-06-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30301691853892 K093109 000

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