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The Dynarex Umbilical Cord Clamp is a device used to compress the umbilical cord. Federal (USA) law restricts this device to sale by or on the order of a physician.

The Dynarex Umbilical Cord Clamp instrument is substantially equivalent in function and intended use to these examples of products presently on the market. Specifically, the Dynarex Umbilical Cord Clamp is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices. The packaging methods and packaging materials are exactly the same, respectively.

This document is a 510(k) premarket notification for the Dynarex Umbilical Cord Clamp. It serves to establish substantial equivalence to a predicate device rather than to describe a study proving the device meets acceptance criteria. As such, the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth methodologies associated with a device performance study are not present in this document.

The document states:

• "The Dynarex Umbilical Cord Clamp instrument is substantially equivalent in function and intended use to these examples of products presently on the market."
• "Specifically, the Dynarex Umbilical Cord Clamp is exactly similar in functional design, performs the same functions and has the same intended use as these presently distributed devices."
• "The Dynarex Umbilical Cord Clamp is indicated for use to compress the umbilical cord and is not different than the predicate device example, therefore the safety, effectiveness and overall function of this device is assured."

Therefore, based on the provided text, there is no information available to answer the specific questions about acceptance criteria and a study proving their fulfillment. The manufacturer is asserting equivalence to an existing device rather than providing new performance data.

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