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

    HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES

    K Number: K050508 · Decision Apr 27, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    2
    Review Days
    58

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    Basic Information

    Device Name
    HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES
    K Number
    K050508
    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
    Haywood Vocational Opportunities
    Date Received
    February 28, 2005
    Decision Date
    April 27, 2005
    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, Antimicrobial

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