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 ID: K093109
• 510k Number: K093109
• Device Name: NOVOTWIST NEEDLE, MODELS 30G * 8MM (1/3) 32 G TIP * 5 MM(1/5')
• Classification: Needle, Hypodermic, Single Lumen
• Applicant: NOVO NORDISK INC. 100 COLLEGE ROAD WEST Princeton, NJ 08540 -7810
• Contact: Cindy Cao
• Correspondent: Cindy Cao; NOVO NORDISK INC. 100 COLLEGE ROAD WEST Princeton, NJ 08540 -7810
• Product Code: FMI
• CFR Regulation Number: 880.5570 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-10-01
• Decision Date: 2010-06-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30301691853892	K093109	000