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

    ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR

    K Number: K980895 · Decision Nov 6, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    156
    Applicant Total
    1
    Review Days
    242

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    Basic Information

    Device Name
    ALLEGRO ULTRASONIC SOFT TISSUE ASPIRATOR
    K Number
    K980895
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    California Institute of Tissue Eng. & Instrumenti
    Date Received
    March 9, 1998
    Decision Date
    November 6, 1998
    Product Code
    LFL
    Advisory Committee
    Unknown
    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
    LFL Instrument, Ultrasonic Surgical

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