Name: Predicase
Price: 199 USD

K-number	K071785
Device name	HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE
Applicant	Smiths Medical Asd, Inc.
Product code	FMI
Device class	Class II
Decision date	Aug 2, 2007
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE, HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE WITH SYRINGE

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