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510(k) Data Aggregation

    K Number
    K982029
    Device Name
    SHARPS COLLECTION CONTAINER - SAF-T-SHELL
    Manufacturer
    AMERICAN MEDICAL MFG., INC.
    Date Cleared
    1999-04-06

    (301 days)

    Product Code
    FMI
    Regulation Number
    880.5570
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN MEDICAL MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The American Medical Manufacturing, Inc. Sharps Collection Container is to be used for collection and disposal of medical sharps in hospitals and doctors' offices.
    Device Description
    The American Medical Manufacturing, Inc. Sharps Collection Container is an accessory to a single lumen hypodermic needle. The proposed device functions in the same manner as predicate devices in that they provide safe collection of sharps such as svringes, needles, and blades. Device Design/Materials Used/Physical Properties: The proposed device is comprised of polypropylene plastic.
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    K Number
    K961454
    Device Name
    AMMI MAGNI-GUARD
    Manufacturer
    AMERICAN MEDICAL MFG., INC.
    Date Cleared
    1996-07-25

    (101 days)

    Product Code
    LYU
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN MEDICAL MFG., INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Magni-Guard functions in the same manner as predicate devices in that it provides protection to the surgical staff during surgical procedures.
    Device Description
    Magni-Guard includes the same components as other marketed predicate devices. The concept of use is to hold it with one hand over a surgical site before releasing clamps from blood vessel grafts or during heavy irrigation to prevent blood splashing. The basic scientific concept that forms the Magni-Guard is that it consists of a clear, rigid, see through plastic. The Guard is made from styrene or PETG. The clear guard has raised side walls throughout its circumference (identical to a Petri-Dish) to prevent the splashing of blood across the surgical suite. It further has an extended handle attached to the circular guard for the surgical site as required intermittently during the surgical procedure.
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