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    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    Sweden & Martina Surgical Tray (Model ZSHORTY-INT)

    K Number: K182084 · Decision Nov 4, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    266
    Registration Numbers
    266
    Same Product Code
    279
    Applicant Total
    8
    Review Days
    825

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    Basic Information

    Device Name
    Sweden & Martina Surgical Tray (Model ZSHORTY-INT)
    K Number
    K182084
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Sweden & Martina S.P.A.
    Date Received
    August 2, 2018
    Decision Date
    November 4, 2020
    Product Code
    KCT
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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    Other Clearances by Sweden & Martina S.P.A.

    K Number Device Name
    K222640 Sweden & Martina Surgical Trays
    K180365 PRAMA White Implant Systems
    K161989 PREMIUM Implant Systems SHELTA Implant Systems
    K172560 PREMIUM ONE Implant Systems
    K162028 PREMIUM - SHELTA Prosthetic Components
    K162004 PREMIUM Implant Systems SHELTA Implant Systems
    K142242 PREMIUM, SHELTA Implant Systems