NovoFine 32G Tip (0.23/0.25) X 6 Mm ETW (extra Thin Wall)

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 32g Tip (0.23/0.25) X 6 Mm Etw (extra Thin Wall).

Pre-market Notification Details

Device IDK173479
510k NumberK173479
Device Name:NovoFine 32G Tip (0.23/0.25) X 6 Mm ETW (extra Thin Wall)
ClassificationNeedle, Hypodermic, Single Lumen
Applicant Novo Nordisk Inc. P.O. Box 846 Plainsboro,  NJ  08536
ContactDevraj Chakravarty
CorrespondentDevraj Chakravarty
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 Received2017-11-13
Decision Date2018-01-17
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.