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

    SAFEDWEEL DRESSING CHANGE TRAY

    K Number: K950438 · Decision Mar 15, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    25
    Review Days
    41

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    Basic Information

    Device Name
    SAFEDWEEL DRESSING CHANGE TRAY
    K Number
    K950438
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Becton Dickinson Vascular Access, Inc.
    Date Received
    February 2, 1995
    Decision Date
    March 15, 1995
    Product Code
    FRG
    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
    FRG Wrap, Sterilization

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