Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz

Dressing, Wound, Drug

Simple Science, LLC

The following data is part of a premarket notification filed by Simple Science, Llc with the FDA for Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz.

Pre-market Notification Details

Device IDK160095
510k NumberK160095
Device Name:Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz
ClassificationDressing, Wound, Drug
Applicant Simple Science, LLC 5555 W 78th St STE M Edina,  MN  55439
ContactEoin Croke
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 Received2016-01-19
Decision Date2016-06-10
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10735282400992 K160095 000
10735282400985 K160095 000

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