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

    Rochal Antimicrobial Wound Gel

    K Number: K192527 · Decision Feb 7, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    5
    Review Days
    147

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    Basic Information

    Device Name
    Rochal Antimicrobial Wound Gel
    K Number
    K192527
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rochal Industries, LLC
    Date Received
    September 13, 2019
    Decision Date
    February 7, 2020
    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 Rochal Industries, LLC

    K Number Device Name
    K182733 Rochal Bioshield Silicone Film
    K161212 Atteris Antimicrobial Skin Protectant
    K160192 Atteris Antimicrobial Skin & Wound Cleanser
    K160684 Atteris No-Sting Skin Protectant