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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 K181074
Device Name Simple Science Antimicrobial Facial and Eyelid Cleanser
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 Received04/24/2018
Decision Date 08/17/2018
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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