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

    CHICK SURIGICAL LIGHT

    K Number: K860739 · Decision Mar 28, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    68
    Registration Numbers
    68
    Same Product Code
    73
    Applicant Total
    9
    Review Days
    29

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    Basic Information

    Device Name
    CHICK SURIGICAL LIGHT
    K Number
    K860739
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Professional Medical Products, Inc.
    Date Received
    February 27, 1986
    Decision Date
    March 28, 1986
    Product Code
    FSY
    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
    FSY Light, Surgical, Ceiling Mounted

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    K830825 YIELD NON-ADHERENT DRESSING
    K822713 DERM-A-TEC SKIN BARRIER FILM
    K820413 AEGIS NON-ADHERENT DRESSING