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A 510(k) may be used for both: New devices that a manufacturer intends to market for the first time When a manufacturer intends to reintroduce a device that has been significantly changed or modified to an extent that might affect its safety or effectiveness

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Source: Eucalyptus-kiwi Fresh grapefruit Blackberry - Lime Yuzu Tangerine Green Apple Coconut-Blueberry Eucalyptus + kiwi: Ingredients: water, stabilizer polydextrose, acidity regulator citric acid, L-Carnitine, taurine, aroma, preservatives (potassium sorbate, sodium benzoate), sweeteners (acesulfame K, sucralose), vitamin B3 (nicotinamide)

The cells were grown at 37 C in a humidified incubator containing 5% CO 2