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

    MEDISEAL CAMERA COVERS

    K Number: K810512 · Decision Mar 13, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    193
    Registration Numbers
    193
    Same Product Code
    17
    Applicant Total
    5
    Review Days
    17

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    Basic Information

    Device Name
    MEDISEAL CAMERA COVERS
    K Number
    K810512
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4160
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Janin Group, Inc.
    Date Received
    February 24, 1981
    Decision Date
    March 13, 1981
    Product Code
    KQM
    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
    KQM Camera, Surgical And Accessories

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