BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    HONGYU DISPOSABLE SURGICAL DRAPES

    K Number: K141324 · Decision Apr 14, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    219
    Registration Numbers
    219
    Same Product Code
    449
    Applicant Total
    2
    Review Days
    329

    Basic Information

    Device Name
    HONGYU DISPOSABLE SURGICAL DRAPES
    K Number
    K141324
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD
    Date Received
    May 20, 2014
    Decision Date
    April 14, 2015
    Product Code
    KKX
    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
    KKX Drape, Surgical

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