BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    CATALOG NUMBER 111 (FACESHIELD)

    K Number: K925290 · Decision Jul 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    877
    Registration Numbers
    878
    Same Product Code
    55
    Applicant Total
    5
    Review Days
    275

    Basic Information

    Device Name
    CATALOG NUMBER 111 (FACESHIELD)
    K Number
    K925290
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    ANSLEY MEDICAL PRODUCTS, INC.
    Date Received
    October 21, 1992
    Decision Date
    July 23, 1993
    Product Code
    LYU
    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
    LYU Accessory, Surgical Apparel

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