BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    REFLECTIVE MIRROR/CO2 LASER SURG CAT. #902002-000

    K Number: K870790 · Decision Apr 1, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    0
    Applicant Total
    23
    Review Days
    34

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    Basic Information

    Device Name
    REFLECTIVE MIRROR/CO2 LASER SURG CAT. #902002-000
    K Number
    K870790
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Lifestream Int'L, Inc.
    Date Received
    February 26, 1987
    Decision Date
    April 1, 1987
    Product Code
    FTX
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FTX Mirror, General & Plastic Surgery

    Other Clearances by Lifestream Int'L, Inc.

    K Number Device Name
    K964571 VISION CARDIOPLEGIA DELIVERY SYSTEM
    K962354 DIOMED 15, 30, 60 SURGICAL DIODE LASER
    K920178 CARDIOTOMY RESERVOIR W/20 MICRON FILITER
    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
    Search all 23 clearances from Lifestream Int'L, Inc. →