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

    STERILE SUGICAL GOWN PACK

    K Number: K914563 · Decision Jan 10, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    2
    Review Days
    87

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    Basic Information

    Device Name
    STERILE SUGICAL GOWN PACK
    K Number
    K914563
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Assured Surgical Products, Inc.
    Date Received
    October 15, 1991
    Decision Date
    January 10, 1992
    Product Code
    FYA
    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
    FYA Gown, Surgical

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    Other Clearances by Assured Surgical Products, Inc.

    K Number Device Name
    K914605 MULTIPLE STERILE SURGICAL DRAPE PACK