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

    STERI-SHIELD

    K Number: K902677 · Decision Aug 17, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    12
    Applicant Total
    7
    Review Days
    60

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    Basic Information

    Device Name
    STERI-SHIELD
    K Number
    K902677
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Biomedical Devices, Inc.
    Date Received
    June 18, 1990
    Decision Date
    August 17, 1990
    Product Code
    FXY
    Advisory Committee
    General, Plastic Surgery
    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
    FXY Hood, Surgical

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