What's New

A guide to 510(k) Premarket Notification

Posted on by Congenius

What is the difference between a Traditional, Abbreviated and Special 510(k)? In which scenario should you use each submission type? And how do you go about preparing and submitting your 510(k) submission? We answer these questions in our latest fact sheet: A guide to 510(k) Premarket Notification. Download the quick-read resource below.


Get in touch

If you have a challenge that you think we could help with, please feel free to get in touch by filling out our contact form or by giving us a call. We look forward to speaking with you!

Congenius AG
Riedstrasse 1
CH-8953 Dietikon

e: info@congenius.ch
t: +41 44 741 04 04