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

    CAVERMAP SURGICAL AID

    K Number: K993436 · Decision Feb 11, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    104
    Registration Numbers
    104
    Same Product Code
    6
    Applicant Total
    10
    Review Days
    122

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    Basic Information

    Device Name
    CAVERMAP SURGICAL AID
    K Number
    K993436
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.4730
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Uromed Corp.
    Date Received
    October 12, 1999
    Decision Date
    February 11, 2000
    Product Code
    FGM
    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
    FGM Probe And Director, Gastro-Urology

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