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

    DISPOSABLE LIGHT HANDLE AND ADAPTOR

    K Number: K020304 · Decision Feb 14, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    93
    Registration Numbers
    93
    Same Product Code
    25
    Applicant Total
    2
    Review Days
    16

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    Basic Information

    Device Name
    DISPOSABLE LIGHT HANDLE AND ADAPTOR
    K Number
    K020304
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4580
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Aspen Surgical Products, Inc.
    Date Received
    January 29, 2002
    Decision Date
    February 14, 2002
    Product Code
    FTA
    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
    FTA Light, Surgical, Accessories

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