Name: Predicase
Price: 199 USD

K-number	K972878
Device name	ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300
Applicant	Safety Syringes, Inc.
Product code	FMF
Device class	Class II
Decision date	Oct 30, 1997
Decision	Substantially Equivalent
Regulation	880.5860

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Source

View the full FDA submission: accessdata.fda.gov

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ULTRASAFE INJECTION SYSTEM NEEDLE GUARD, MODELS B50,B100L,B150,B225, AND B300

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