FDA 510(k) Applications Submitted by NOVO NORDISK INC.

FDA 510(k) Number Submission Date Device Name Applicant
K093109 10/01/2009 NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5') NOVO NORDISK INC.
K173479 11/13/2017 NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) Novo Nordisk Inc.
K182387 09/04/2018 NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) Novo Nordisk Inc.
K162602 09/19/2016 NovoPen Echo Novo Nordisk Inc.
K210258 02/01/2021 NovoFine Novo Nordisk Inc.
K231255 05/01/2023 NovoFine« Plus Novo Nordisk Inc.
K202005 07/21/2020 NovoFine Plus 32G Tip x 4 mm Novo Nordisk Inc.
K050106 01/18/2005 NOVOFINE AUTOCOVER 30G X 8MM NOVO NORDISK INC.
K053470 12/14/2005 NOVOFINE 32G TIP NOVO NORDISK INC.
K123766 12/07/2012 NOVOPEN ECHO, A DIAL A DOSE INSULIN DELIVERY PEN NOVO NORDISK INC.
K150874 04/01/2015 NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) NOVO NORDISK INC.
K090111 01/16/2009 FLEXPEN NEEDLE NOVO NORDISK INC.
K062500 08/25/2006 FLEXPEN NEEDLE NOVO NORDISK INC.
K133738 12/09/2013 NOVOFINE PLUS 32G 4 MM NOVO NORDISK INC.


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