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

    CALCULI FILTER CUP

    K Number: K820180 · Decision Feb 5, 1982
    View on FDA
    Classifications
    1
    FEI Numbers
    294
    Registration Numbers
    294
    Same Product Code
    22
    Applicant Total
    6
    Review Days
    14

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    Basic Information

    Device Name
    CALCULI FILTER CUP
    K Number
    K820180
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    864.3250
    Medical Specialty
    Pathology
    Decision
    Substantially Equivalent
    Applicant
    Omnimedical
    Date Received
    January 22, 1982
    Decision Date
    February 5, 1982
    Product Code
    FMH
    Advisory Committee
    Pathology
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FMH Container, Specimen, Sterile

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