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

    MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL

    K Number: K955149 · Decision Jan 24, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    174
    Registration Numbers
    174
    Same Product Code
    23
    Applicant Total
    7
    Review Days
    72

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    Basic Information

    Device Name
    MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL
    K Number
    K955149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6740
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bio-Medical Devices, Inc.
    Date Received
    November 13, 1995
    Decision Date
    January 24, 1996
    Product Code
    BYY
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    BYY Tube, Aspirating, Flexible, Connecting

    Similar 510(k) Clearances

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    MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR

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    WILTEK IRRIGAITON/ASPIRATION TUBE SET

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    GENERAL HOSPITAL TUBING CLAMP (NON-ELECTRIC)

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    Other Clearances by Bio-Medical Devices, Inc.

    K Number Device Name
    K040485 MAXAIR SURGICAL HELMET SYSTEM
    K981888 SMOKE-EVAC
    K955151 MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR
    K955150 MAXI-FLOW
    K940156 THE REEL THING
    K933742 TOP GUN