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

    DURALASTIC SHEETING II

    K Number: K961057 · Decision May 16, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    44
    Applicant Total
    10
    Review Days
    59

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    Basic Information

    Device Name
    DURALASTIC SHEETING II
    K Number
    K961057
    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
    Rand Scientific Corp.
    Date Received
    March 18, 1996
    Decision Date
    May 16, 1996
    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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    K952165 TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS