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

    VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS

    K Number: K864822 · Decision Jan 15, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    94
    Registration Numbers
    94
    Same Product Code
    18
    Applicant Total
    6
    Review Days
    37

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    Basic Information

    Device Name
    VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS
    K Number
    K864822
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5320
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Surgidyne, Inc.
    Date Received
    December 9, 1986
    Decision Date
    January 15, 1987
    Product Code
    BTC
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BTC Bag, Reservoir

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