K-number	K193476
Device name	VariLymph 12 pro
Applicant	Slk Medical GmbH
Product code	JOW
Device class	Class II
Decision date	Aug 19, 2020
Decision	Substantially Equivalent
Regulation	870.5800

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Source

View the full FDA submission: accessdata.fda.gov

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VariLymph 12 pro

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