Name: Predicase
Price: 199 USD

K-number	K123084
Device name	DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD
Applicant	Elcam Medical Acal
Product code	FMG
Device class	Class II
Decision date	May 23, 2013
Decision	Substantially Equivalent
Regulation	880.5440

AI Summary

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Source

View the full FDA submission: accessdata.fda.gov

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DISPOSABLE HIGH PRESSURE STOPCOCK/MANIFOLD MODEL HP STOPCOCK, MP STOPCOCK, HP MANIFOLD, PHP MANIFOLD

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