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

    SUCTION-OFF

    K Number: K863653 · Decision Oct 7, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    342
    Registration Numbers
    342
    Same Product Code
    13
    Applicant Total
    23
    Review Days
    19

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    Basic Information

    Device Name
    SUCTION-OFF
    K Number
    K863653
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    B&B Medical Technologies, Inc.
    Date Received
    September 18, 1986
    Decision Date
    October 7, 1986
    Product Code
    HXD
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HXD Clamp

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