BEUDAMED
    FDA 510(k) FDA class 3 Substantially Equivalent 🇺🇸 United States

    LM-150HT LIGHT SOURCE

    K Number: K911212 · Decision May 23, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    10
    Review Days
    65

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    Basic Information

    Device Name
    LM-150HT LIGHT SOURCE
    K Number
    K911212
    Device Class
    FDA class 3
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Applicant
    Leisegang Medical, Inc.
    Date Received
    March 19, 1991
    Decision Date
    May 23, 1991
    Product Code
    ESI
    Advisory Committee
    Unknown
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ESI Polymer, Natural-Absorbable Gelatin Material

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