K-number	K871843
Device name	TWO FLUID W/CHECK VALVE
Applicant	Panamedix, Inc.
Product code	FPA
Device class	Class II
Decision date	Jul 21, 1987
Decision	Substantially Equivalent
Regulation	880.5440

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Source

View the full FDA submission: accessdata.fda.gov

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TWO FLUID W/CHECK VALVE

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