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

    KEY COMFORT GRIPS

    K Number: K910328 · Decision Mar 6, 1991
    View on FDA
    Classifications
    1
    FEI Numbers
    875
    Registration Numbers
    875
    Same Product Code
    75
    Applicant Total
    6
    Review Days
    40

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    Basic Information

    Device Name
    KEY COMFORT GRIPS
    K Number
    K910328
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Key Surgical, Inc.
    Date Received
    January 25, 1991
    Decision Date
    March 6, 1991
    Product Code
    FSM
    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
    FSM Tray, Surgical, Instrument

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    ARTHROSCOPY TRAY

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    HEART CATH TRAY

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