CleanSmart Wound Cleanser

Dressing, Wound, Drug

SIMPLE SCIENCE, LLC

The following data is part of a premarket notification filed by Simple Science, Llc with the FDA for Cleansmart Wound Cleanser.

Pre-market Notification Details

Device IDK142592
510k NumberK142592
Device Name:CleanSmart Wound Cleanser
ClassificationDressing, Wound, Drug
Applicant SIMPLE SCIENCE, LLC 530 NORTH 3RD STREET SUITE 310 Minneapolis,  MN  55401
ContactJustin Scanlan
CorrespondentEoin Croke
Simple Science, LLC 5555 W 78th St STE M Edina,  MN  55439
Product CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2014-09-15
Decision Date2015-09-02
Summary:summary

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