BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇻🇬 Virgin Islands, British

    SILGEL TOPICAL GEL SHEET

    K Number: K974172 · Decision Mar 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    190
    Registration Numbers
    190
    Same Product Code
    80
    Applicant Total
    2
    Review Days
    145

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    Basic Information

    Device Name
    SILGEL TOPICAL GEL SHEET
    K Number
    K974172
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4025
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nagor , Ltd.
    Date Received
    November 5, 1997
    Decision Date
    March 30, 1998
    Product Code
    MDA
    Advisory Committee
    General, Plastic Surgery
    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
    MDA Elastomer, Silicone, For Scar Management

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