Name: Predicase
Price: 199 USD

K-number	K964918
Device name	NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS
Applicant	Critical Device Corp.
Product code	FPA
Device class	Class II
Decision date	Apr 14, 1997
Decision	Substantially Equivalent
Regulation	880.5440

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Source

View the full FDA submission: accessdata.fda.gov

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NIMA NEEDLELESS INJECTIONSITE MASTER ADAPTER WITH POSIFLOW POSITIVE DISPLACEMENT FEATURE, AND I.V. SETS

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