BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent for Some Indications 🇺🇸 United States

    SALINE DRESSING

    K Number: K952948 · Decision Aug 16, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    402
    Registration Numbers
    403
    Same Product Code
    861
    Applicant Total
    31
    Review Days
    51

    Basic Information

    Device Name
    SALINE DRESSING
    K Number
    K952948
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    BUSSE HOSPITAL DISPOSABLES, INC.
    Date Received
    June 26, 1995
    Decision Date
    August 16, 1995
    Product Code
    FRO
    Advisory Committee
    Unknown
    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
    FRO Dressing, Wound, Drug

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