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

    EPI-DERM SILICONE GEL SHEETING

    K Number: K003948 · Decision Jan 29, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    190
    Registration Numbers
    190
    Same Product Code
    80
    Applicant Total
    5
    Review Days
    39

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    Basic Information

    Device Name
    EPI-DERM SILICONE GEL SHEETING
    K Number
    K003948
    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
    Biodermis Corp.
    Date Received
    December 21, 2000
    Decision Date
    January 29, 2001
    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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    Other Clearances by Biodermis Corp.

    K Number Device Name
    K992146 SCARAID SILICONE GEL SHEETING
    K991604 EPI-FOAM SILICONE SHEETING
    K964047 CRYOSIL SILICONE GEL SHEETING
    K942156 EPI-DERM SILICONE GEL SHEETING