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An intravascular catheter, inserted peripherally for long-term administration of solutions for parenteral nutrition and/or administration of drugs

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The provided text is a 510(k) premarket notification letter from the FDA to Vygon US LLC regarding their Nutriline and Nutriline Twinflow Catheters. This document does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The letter primarily:

• Confirms the review of the 510(k) submission (K052475).
• States that the device is substantially equivalent to legally marketed predicate devices.
• Informs the manufacturer about general controls and other applicable regulations.
• Encloses the "Indications for Use" for the device.

Therefore, I cannot provide the requested information from the given text. A 510(k) summary or a more detailed submission document would typically contain such study information if it were required for the substantial equivalence demonstration.

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