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

    WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY

    K Number: K980137 · Decision Jan 30, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    165
    Registration Numbers
    165
    Same Product Code
    109
    Applicant Total
    15
    Review Days
    15

    Basic Information

    Device Name
    WORLDWIDE MEDICAL TECHNOLOGIES BONE MARROW BIOPSY PROCEDURE TRAY
    K Number
    K980137
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    WORLDWIDE MEDICAL TECHNOLOGIES, LLC
    Date Received
    January 15, 1998
    Decision Date
    January 30, 1998
    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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