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

    BUSSE PLASTIC LOR SYRINGE

    K Number: K080804 · Decision Jul 9, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    81
    Registration Numbers
    81
    Same Product Code
    154
    Applicant Total
    2
    Review Days
    110

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    Basic Information

    Device Name
    BUSSE PLASTIC LOR SYRINGE
    K Number
    K080804
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    868.5140
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Busse Hosipital Disposables
    Date Received
    March 21, 2008
    Decision Date
    July 9, 2008
    Product Code
    CAZ
    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
    CAZ Anesthesia Conduction Kit

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    Other Clearances by Busse Hosipital Disposables

    K Number Device Name
    K083424 BUSSE SURGICAL DRAPE