K-number	K142592
Device name	CleanSmart Wound Cleanser
Applicant	Simple Science, LLC
Product code	FRO
Device class	Class U
Decision date	Sep 2, 2015
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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CleanSmart Wound Cleanser

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