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

    STERILE CONVERTOR SAFECARE GOWN AND DRAPE

    K Number: K920837 · Decision May 22, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    505
    Review Days
    88

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    Basic Information

    Device Name
    STERILE CONVERTOR SAFECARE GOWN AND DRAPE
    K Number
    K920837
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Baxter Healthcare Corp
    Date Received
    February 24, 1992
    Decision Date
    May 22, 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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