K-number	K915828
Device name	INJECTION SITE WITH LUER LOCK
Applicant	Baxter Healthcare Corp
Product code	FPA
Device class	Class II
Decision date	May 15, 1992
Decision	Substantially Equivalent
Regulation	880.5440

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Source

View the full FDA submission: accessdata.fda.gov

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INJECTION SITE WITH LUER LOCK

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