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

    Microcyn Plus Antimicrobial Wound Care Solution

    K Number: K172851 · Decision Nov 15, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    402
    Registration Numbers
    403
    Same Product Code
    861
    Applicant Total
    5
    Review Days
    56

    Basic Information

    Device Name
    Microcyn Plus Antimicrobial Wound Care Solution
    K Number
    K172851
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sonoma Pharmaceuticals, Inc.
    Date Received
    September 20, 2017
    Decision Date
    November 15, 2017
    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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