Purpose Of A 510 (K)

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The purpose of a 510(k) premarket notification to obtain a marketing clearance saying that the medical device is safe, effective as other legally marketed equipment or a standard that is used for the same purpose. Basically, medical equipment must be in the same level of effectiveness and safety as the predicate device in order to be eligible for 510(k) clearance. The comparison depends on many factors such as the purpose of the device, performance characteristics, features, and the degree of risk while using it. For instance, Premarket Notification submissions for Infusion Pumps are based on their purpose and functionality while Premarket Notification submissions for medical gloves are based on their physical characteristic.

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