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

    DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER

    K Number: K871068 · Decision May 28, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    200
    Registration Numbers
    200
    Same Product Code
    449
    Applicant Total
    23
    Review Days
    71

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    Basic Information

    Device Name
    DISPOSABLE LASER PROTECTIVE DRAPE FOR CO2 LASER
    K Number
    K871068
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Lifestream Int'L, Inc.
    Date Received
    March 18, 1987
    Decision Date
    May 28, 1987
    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 Lifestream Int'L, Inc.

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    K920618 AUTOTRANSFUSION SUCTION SET
    K913181 AUTOLOGOUS BLOOD PROCESSING SYSTEM
    K914396 SURGI LIGHT NON-CONTACT FIBERS
    K912045 TMP PRESSURE ISOLATORR, TMP PRESSURE MONITOR SYST
    K911523 MODIFICATION TO MODEL 90-1460 LASER ADAPTER
    K910726 LIGHT-TOUCH AND SURGI LIGHT FIBERS
    K904491 TMP LEFT ATRIAL PRESSURE CATH CAT.# 100-00X-000
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