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

    COMFORT MACHINE FOR DESENSITIZATION/ANESTHESIA USE

    K Number: K873605 · Decision Dec 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    14
    Applicant Total
    1
    Review Days
    117

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    Basic Information

    Device Name
    COMFORT MACHINE FOR DESENSITIZATION/ANESTHESIA USE
    K Number
    K873605
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Pain Prevention Laboratory, Inc.
    Date Received
    September 4, 1987
    Decision Date
    December 30, 1987
    Product Code
    LWM
    Advisory Committee
    Unknown
    Review Advisory Committee
    DE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LWM Device, Electrical Dental Anesthesia

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