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

    BORES* ADJUSTABLE BLADE HOLDER

    K Number: K812070 · Decision Aug 18, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    430
    Registration Numbers
    430
    Same Product Code
    15
    Applicant Total
    8
    Review Days
    28

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    Basic Information

    Device Name
    BORES* ADJUSTABLE BLADE HOLDER
    K Number
    K812070
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Santa Barbara Medco, Inc.
    Date Received
    July 21, 1981
    Decision Date
    August 18, 1981
    Product Code
    GDZ
    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
    GDZ Handle, Scalpel

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    Other Clearances by Santa Barbara Medco, Inc.

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    K821187 MEDCO CUSTOM EAR PROTECTOR MOLD KIT
    K812069 BORES* DEPTH GAUGE
    K812071 RK IV SURGICAL BLADES
    K802638 OTOLOGICAL VENTILATION TUBES