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

    SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH

    K Number: K030684 · Decision Jun 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    5
    Applicant Total
    16
    Review Days
    90

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    Basic Information

    Device Name
    SCOPE GUARD PROTECTIVE SHEATH, MODEL TEL-SH
    K Number
    K030684
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Acmi Corporation
    Date Received
    March 5, 2003
    Decision Date
    June 3, 2003
    Product Code
    OCU
    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
    OCU Endoscopic Storage Cover

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