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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K160095
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
Applicant
Simple Science, LLC
5555 W 78th St. Suite M
Edina,  MN  55439
Applicant Contact Eoin Croke
Correspondent
Simple Science, LLC
5555 W 78th St. Suite M
Edina,  MN  55439
Correspondent Contact Eoin Croke
Classification Product Code
FRO  
Date Received01/19/2016
Decision Date 06/10/2016
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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