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510(k) Data Aggregation
K Number
K982029Device Name
SHARPS COLLECTION CONTAINER - SAF-T-SHELL
Manufacturer
AMERICAN MEDICAL MFG., INC.
Date Cleared
1999-04-06
(301 days)
Product Code
FMI
Regulation Number
880.5570Why 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
K961454Device Name
AMMI MAGNI-GUARD
Manufacturer
AMERICAN MEDICAL MFG., INC.
Date Cleared
1996-07-25
(101 days)
Product Code
LYU
Regulation Number
878.4040Why 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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