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

    SINGLE USE INSTRUMENT TRAY

    K Number: K951149 · Decision Apr 6, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    109
    Applicant Total
    11
    Review Days
    24

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    Basic Information

    Device Name
    SINGLE USE INSTRUMENT TRAY
    K Number
    K951149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Medcare Custom Packaging, Inc.
    Date Received
    March 13, 1995
    Decision Date
    April 6, 1995
    Product Code
    LRO
    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
    LRO General Surgery Tray

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