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

    EYE TRAY

    K Number: K912105 · Decision Aug 29, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    285
    Registration Numbers
    286
    Same Product Code
    21
    Applicant Total
    30
    Review Days
    108

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    Basic Information

    Device Name
    EYE TRAY
    K Number
    K912105
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Medical Device Inspection Co., Inc.
    Date Received
    May 13, 1991
    Decision Date
    August 29, 1991
    Product Code
    LRP
    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
    LRP Tray, Surgical

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