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    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    ISOLATION GOWN

    K Number: K960999 · Decision Dec 30, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    67
    Applicant Total
    8
    Review Days
    293

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    Basic Information

    Device Name
    ISOLATION GOWN
    K Number
    K960999
    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
    Copioumed Intl., Inc.
    Date Received
    March 12, 1996
    Decision Date
    December 30, 1996
    Product Code
    FYC
    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
    FYC Gown, Isolation, Surgical

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    K965237 NURSES BOUFFANT CAP
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