Name: Predicase
Price: 199 USD

K-number	K090959
Device name	LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA
Applicant	D'Antonio Consultants International, Inc. (Dci)
Product code	KZE
Device class	Class II
Decision date	Dec 24, 2009
Decision	Substantially Equivalent
Regulation	880.5430

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Source

View the full FDA submission: accessdata.fda.gov

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LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RA

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