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

    KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100

    K Number: K093115 · Decision Mar 19, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    222
    Registration Numbers
    222
    Same Product Code
    294
    Applicant Total
    104
    Review Days
    168

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    Basic Information

    Device Name
    KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100
    K Number
    K093115
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Kimberly-Clark Corp.
    Date Received
    October 2, 2009
    Decision Date
    March 19, 2010
    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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