BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    WHITESIDE ACRYLIC CEMENT SPACER SLEEVE

    K Number: K844637 · Decision Jun 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    0
    Applicant Total
    31
    Review Days
    203

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    Basic Information

    Device Name
    WHITESIDE ACRYLIC CEMENT SPACER SLEEVE
    K Number
    K844637
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Dow Corning Corp. Healthcare Industries Materials
    Date Received
    November 28, 1984
    Decision Date
    June 19, 1985
    Product Code
    LTC
    Advisory Committee
    Unknown
    Review Advisory Committee
    CH
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LTC Hyaline Membrane Disease Assay

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