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For use in dispensing liquid nutrients (feeding solutions) by connecting an enteral feeding container to a patient's feeding tube.
For connecting a universal enteral spike set to a feeding container having a SpikeRight™ connection port.

Enteral Feeding Spike Adapter to be used for enteral administration. This device serves as a connection between the feeding container and the enteral set (gravity or pump fed).

The provided text is a 510(k) summary for the Cedic Enteral Feeding Spike Adapter. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not contain information about acceptance criteria or specific study results proving the device meets acceptance criteria.

The document is a submission to the FDA for market clearance, where the primary goal is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than to present detailed performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given input. The document focuses on regulatory comparison, not performance testing against defined criteria.

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