NovoFine Plus 32G Tip X 4 Mm

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 Novofine Plus 32g Tip X 4 Mm.

Pre-market Notification Details

Device IDK202005
510k NumberK202005
Device Name:NovoFine Plus 32G Tip X 4 Mm
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Novo Nordisk Inc. P.O Box 846 Plainsboro,  NJ  08536
ContactHiral Palkhiwala Shah
CorrespondentHiral Palkhiwala Shah
Novo Nordisk Inc. P.O Box 846 Plainsboro,  NJ  08536
Product CodeFMI  
CFR Regulation Number880.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-21
Decision Date2020-12-19

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.