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

    BURN DRESSING TRAY

    K Number: K942000 · Decision May 20, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    194
    Registration Numbers
    194
    Same Product Code
    321
    Applicant Total
    11
    Review Days
    25

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    Basic Information

    Device Name
    BURN DRESSING TRAY
    K Number
    K942000
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.6850
    Medical Specialty
    General Hospital
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Medcare Custom Packaging, Inc.
    Date Received
    April 25, 1994
    Decision Date
    May 20, 1994
    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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