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

    TOP GUN

    K Number: K933742 · Decision Apr 7, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    146
    Registration Numbers
    146
    Same Product Code
    52
    Applicant Total
    7
    Review Days
    247

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    Basic Information

    Device Name
    TOP GUN
    K Number
    K933742
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5475
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Bio-Medical Devices, Inc.
    Date Received
    August 3, 1993
    Decision Date
    April 7, 1994
    Product Code
    FQH
    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
    FQH Lavage, Jet

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    Other Clearances by Bio-Medical Devices, Inc.

    K Number Device Name
    K040485 MAXAIR SURGICAL HELMET SYSTEM
    K981888 SMOKE-EVAC
    K955149 MAXI-FLOW SUCTION HANDLE/THE REEL THING TUBING REEL
    K955151 MAXI-FLOW SUCTION TUBE/TOP GUN SUCTION IRRIGATOR
    K955150 MAXI-FLOW
    K940156 THE REEL THING