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

    PERLINK CASSETTE, KIRAN CASSETTE

    K Number: K896708 · Decision May 7, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    50
    Applicant Total
    6
    Review Days
    160

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    Basic Information

    Device Name
    PERLINK CASSETTE, KIRAN CASSETTE
    K Number
    K896708
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1850
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Perlink USA, Inc.
    Date Received
    November 28, 1989
    Decision Date
    May 7, 1990
    Product Code
    IXA
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IXA Cassette, Radiographic Film

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    Other Clearances by Perlink USA, Inc.

    K Number Device Name
    K922358 STERLING POWDER FREE PATIENT EXAMINATION GLOVES
    K924959 STERLING LATEX EXAM GLOVE, HYPO-ALLERGENIC
    K921438 DISPOSABLE LATEX EXAMINATION GLOVES
    K896707 PERLINK SCREEN, KIRAN SCREEN
    K901790 THERMOMETER, MERCURY/CLINICAL