K-number	K190119
Device name	Foryou NPWT Dressing Kit
Applicant	4l Health Co., Ltd.
Product code	OMP
Device class	Class II
Decision date	Nov 1, 2019
Decision	Substantially Equivalent
Regulation	878.4780

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Source

View the full FDA submission: accessdata.fda.gov

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Foryou NPWT Dressing Kit

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