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For the Augmentation or cosmetic alteration of the nasal shape or contour by straightening the nasal dorsum or widening the narrow nose.

The Monarch Nasal Implant is a Class II Device. The Monarch Nasal Implant is available in 48mm and 44mm lengths and is 1cm wide at the ends. The thickness is 1.5mm to 2mm around the edges. The Monarch Nasal Implant may be inserted via three approaches: Transcutaneous, Intercartilaginous Approach and The Open Technique. The Monarch Nasal Implant is comprised of ePTFE and Medical Grade Titanium Alloys.

The provided text is a 510(k) summary statement for the Monarch Nasal Implant. It states the intended use of the device and information about its materials, sterilization, and sizing. However, it does not include any acceptance criteria, performance data, or details of a study that proves the device meets specific criteria.

Therefore, I cannot provide the requested table and study information based on the input text. The document is primarily focused on establishing substantial equivalence to predicate devices for regulatory approval, rather than detailing performance studies.

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