BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SILGEL TOPICAL GEL SHEET

    K Number: K960254 · Decision Apr 2, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    190
    Registration Numbers
    190
    Same Product Code
    80
    Applicant Total
    1
    Review Days
    76

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    Basic Information

    Device Name
    SILGEL TOPICAL GEL SHEET
    K Number
    K960254
    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
    Rofil Medical USA, Inc.
    Date Received
    January 17, 1996
    Decision Date
    April 2, 1996
    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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