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

    LS1000 SURGICAL ASPIRATOR II

    K Number: K854844 · Decision Feb 12, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    158
    Applicant Total
    5
    Review Days
    70

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    Basic Information

    Device Name
    LS1000 SURGICAL ASPIRATOR II
    K Number
    K854844
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4780
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Engineering, Inc.
    Date Received
    December 4, 1985
    Decision Date
    February 12, 1986
    Product Code
    BTA
    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
    BTA Pump, Portable, Aspiration (Manual Or Powered)

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    Other Clearances by Engineering, Inc.

    K Number Device Name
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    K854359 LM2000A SURGICAL SUCTION MONITOR