Name: Predicase
Price: 199 USD

K-number	K020786
Device name	INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM
Applicant	Rosch AG Medizintechnic
Product code	KZE
Device class	Class II
Decision date	Sep 25, 2002
Decision	Substantially Equivalent
Regulation	880.5430

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Source

View the full FDA submission: accessdata.fda.gov

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INJEX NEEDLE-FREE INJECTION SYSTEM; ROJEX NEEDLE-FREE INJECTION SYSTEM

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