BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇩🇰 Denmark

    Biatain Silicone Ag

    K Number: K191536 · Decision Feb 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    384
    Registration Numbers
    385
    Same Product Code
    702
    Applicant Total
    71
    Review Days
    256

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    Basic Information

    Device Name
    Biatain Silicone Ag
    K Number
    K191536
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Coloplast A/S
    Date Received
    June 10, 2019
    Decision Date
    February 21, 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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