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

    OMED DISPOSABLE SCALPEL

    K Number: K880028 · Decision Jan 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    25
    Applicant Total
    6
    Review Days
    24

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    Basic Information

    Device Name
    OMED DISPOSABLE SCALPEL
    K Number
    K880028
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Oxboro Medical Intl., Inc.
    Date Received
    January 5, 1988
    Decision Date
    January 29, 1988
    Product Code
    GDX
    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
    GDX Scalpel, One-Piece

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