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

    ABDOMINAL / THORACIC PATIENT DRAPE

    K Number: K930815 · Decision May 5, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    13
    Review Days
    442

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    Basic Information

    Device Name
    ABDOMINAL / THORACIC PATIENT DRAPE
    K Number
    K930815
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Custom Medical Products, Ltd.
    Date Received
    February 17, 1993
    Decision Date
    May 5, 1994
    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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    Other Clearances by Custom Medical Products, Ltd.

    K Number Device Name
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    K931844 CUSTOM PROCEDURE MEDICAL TRAY OR KIT
    K926519 SURGICAL GOWN
    K900847 ENEMA KIT 'Y' DESIGN
    K900848 ENEMA KIT 'STRAIGHT' DESIGN
    K895084 APERTURE
    K893681 MAMM-AIRE CP
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