K-number	K152930
Device name	PeriFlux6000
Applicant	Perimed AB
Product code	DPW
Device class	Class II
Decision date	May 5, 2016
Decision	Substantially Equivalent
Regulation	870.2100

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Source

View the full FDA submission: accessdata.fda.gov

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PeriFlux6000

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