Name: Predicase
Price: 199 USD

K-number	K032976
Device name	BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001
Applicant	Biovalve Technologies, Inc.
Product code	KZE
Device class	Class II
Decision date	Apr 16, 2004
Decision	Substantially Equivalent
Regulation	880.5430

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Source

View the full FDA submission: accessdata.fda.gov

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BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001

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