BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    DURALASTIC SHEETING

    K Number: K945552 · Decision Jan 31, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    44
    Applicant Total
    7
    Review Days
    82

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    Basic Information

    Device Name
    DURALASTIC SHEETING
    K Number
    K945552
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3620
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Applied Biomaterial Technologies
    Date Received
    November 10, 1994
    Decision Date
    January 31, 1995
    Product Code
    MIB
    Advisory Committee
    Ear, Nose, Throat
    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
    MIB Elastomer, Silicone Block

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    Other Clearances by Applied Biomaterial Technologies

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    K935571 DURALASTIC SHEETING
    K931500 THE PERMARIDGE MATRIX CHIN
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    K902285 THE MAGNUM CHIN IMPLANT
    K902284 ZYMALAR IMPLANT
    K902283 THE NAUTILUS NASAL IMPLANT