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

    SHIKANI-FRENCH SPEAKING VALVE

    K Number: K982128 · Decision Oct 23, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    108
    Applicant Total
    5
    Review Days
    128

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    Basic Information

    Device Name
    SHIKANI-FRENCH SPEAKING VALVE
    K Number
    K982128
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pilling Weck Surgical
    Date Received
    June 17, 1998
    Decision Date
    October 23, 1998
    Product Code
    JOH
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    JOH Tube Tracheostomy And Tube Cuff

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    Other Clearances by Pilling Weck Surgical

    K Number Device Name
    K992476 PILLING WECK SURGICAL HEART STABILIZER REMOVABLE PADS
    K992174 PILLING WECK SURGICAL AORTIC SPOON-JAW CLAMP
    K990935 JACKSON ESOPHAGEAL DILATOR
    K990561 OPTICAL FORCEPS