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

    SILON SILICONE FOAM SHEETING

    K Number: K946362 · Decision Jul 13, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    190
    Registration Numbers
    190
    Same Product Code
    80
    Applicant Total
    10
    Review Days
    217

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    Basic Information

    Device Name
    SILON SILICONE FOAM SHEETING
    K Number
    K946362
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4025
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bio Med Sciences, Inc.
    Date Received
    December 8, 1994
    Decision Date
    July 13, 1995
    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 Bio Med Sciences, Inc.

    K Number Device Name
    K023136 OLEEVA FABRIC
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    K990042 SILON DUAL-DRESS
    K982036 SILON SCAR STRIPS
    K952546 SILON SILICONE TEXTILE COMPOSITE
    K945892 SILON(R) SILICONE THERMOPLASTIC SHEETING
    K932214 SILON SILICONE GEL SHEET
    K923150 SILON TRANSPARENT WOUND DRESSINGS
    K912032 SILON(TM) TRANSPARENT WOUND DRESSING