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

    QB II BLUNT DISSECTOR

    K Number: K933604 · Decision Sep 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    58

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    Basic Information

    Device Name
    QB II BLUNT DISSECTOR
    K Number
    K933604
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Joyce M. Shotwell, M.D.
    Date Received
    July 27, 1993
    Decision Date
    September 23, 1993
    Product Code
    FGS
    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
    FGS Carrier, Sponge, Endoscopic

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