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

    P-S MEDICAL BERLIN VISADUCT KIT

    K Number: K832677 · Decision Dec 8, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    117
    Registration Numbers
    117
    Same Product Code
    43
    Applicant Total
    40
    Review Days
    121

    Basic Information

    Device Name
    P-S MEDICAL BERLIN VISADUCT KIT
    K Number
    K832677
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.4730
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    PUDENZ-SCHULTE MEDICAL RESEARCH CORP.
    Date Received
    August 9, 1983
    Decision Date
    December 8, 1983
    Product Code
    KOA
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    KOA Surgical Instruments, G-U, Manual (And Accessories)

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