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

    MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS

    K Number: K993170 · Decision Mar 2, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    218
    Registration Numbers
    218
    Same Product Code
    287
    Applicant Total
    165
    Review Days
    162

    Basic Information

    Device Name
    MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS
    K Number
    K993170
    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
    MEDLINE INDUSTRIES, INC.
    Date Received
    September 22, 1999
    Decision Date
    March 2, 2000
    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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