BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    FLEX-TEMPLATE

    K Number: K811280 · Decision Jun 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    231
    Registration Numbers
    231
    Same Product Code
    66
    Applicant Total
    43
    Review Days
    25

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    Basic Information

    Device Name
    FLEX-TEMPLATE
    K Number
    K811280
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Mick Radio-Nuclear Instruments, Inc.
    Date Received
    May 8, 1981
    Decision Date
    June 2, 1981
    Product Code
    KDC
    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
    KDC Instrument, Surgical, Disposable

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    INSTRUMENT ORGANIZER

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