K-number	K150711
Device name	Salem Sump Dual Lumen Stomach Tube with Multi-functional Port
Applicant	Covidien
Product code	PIF
Device class	Class II
Decision date	Oct 8, 2015
Decision	Substantially Equivalent
Regulation	876.5980

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Source

View the full FDA submission: accessdata.fda.gov

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Salem Sump Dual Lumen Stomach Tube with Multi-functional Port

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