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

    LIFETECH CASSETTE

    K Number: K960756 · Decision Aug 29, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    553

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    Basic Information

    Device Name
    LIFETECH CASSETTE
    K Number
    K960756
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5650
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Lifetech Systems, Inc.
    Date Received
    February 23, 1996
    Decision Date
    August 29, 1997
    Product Code
    KPJ
    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
    KPJ Chamber, Oxygen, Topical, Extremity

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