Name: Predicase
Price: 199 USD

K-number	K970737
Device name	B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE
Applicant	Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code	FMI
Device class	Class II
Decision date	Mar 28, 1997
Decision	Substantially Equivalent
Regulation	880.5570

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Source

View the full FDA submission: accessdata.fda.gov

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B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE

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