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

    VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM

    K Number: K883582 · Decision Oct 3, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    6
    Review Days
    42

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    Basic Information

    Device Name
    VARIDYNE MODEL 250 SUCTION DRAINAGE SYSTEM
    K Number
    K883582
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Surgidyne, Inc.
    Date Received
    August 22, 1988
    Decision Date
    October 3, 1988
    Product Code
    BTA
    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
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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    Other Clearances by Surgidyne, Inc.

    K Number Device Name
    K892334 LEONARD TUBE
    K864822 VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS
    K860030 SURGIDYNE VARIDYNE, MODEL 140-2I & MODEL 140-2ID
    K852180 SURGIDYNES VARIDYNE 350-2I & 350-2C CORDLESS ELEC.
    K850634 SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS