BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    Simple Science Antimicrobial Facial and Eyelid Cleanser

    K Number: K181074 · Decision Aug 17, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    3
    Review Days
    115

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    Basic Information

    Device Name
    Simple Science Antimicrobial Facial and Eyelid Cleanser
    K Number
    K181074
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Simple Science, LLC
    Date Received
    April 24, 2018
    Decision Date
    August 17, 2018
    Product Code
    FRO
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FRO Dressing, Wound, Drug

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    Other Clearances by Simple Science, LLC

    K Number Device Name
    K160095 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
    K142592 CleanSmart Wound Cleanser