K-number	K153513
Device name	Insufflator 50L FM134
Applicant	W.O.M. World of Medicine GmbH
Product code	HIF
Device class	Class II
Decision date	Mar 4, 2016
Decision	Substantially Equivalent
Regulation	884.1730

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Source

View the full FDA submission: accessdata.fda.gov

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Insufflator 50L FM134

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