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

    DRESSING CHANGE TRAYS

    K Number: K963260 · Decision Nov 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    747
    Applicant Total
    31
    Review Days
    94

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    Basic Information

    Device Name
    DRESSING CHANGE TRAYS
    K Number
    K963260
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5860
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Busse Hospital Disposables, Inc.
    Date Received
    August 20, 1996
    Decision Date
    November 22, 1996
    Product Code
    FMF
    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
    FMF Syringe, Piston

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