Name: Predicase
Price: 199 USD

K-number	K150662
Device name	Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)
Applicant	Ypsomed AG
Product code	FMI
Device class	Class II
Decision date	Jun 9, 2015
Decision	Substantially Equivalent
Regulation	880.5570

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)

Everything you need for a 510(k) submission. Nothing you don't.