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Intracavity Needle Guide Kit

This document is a 510(k) clearance letter from the FDA for an "Intracavity Needle Guide Kit." It states that the device has been determined to be substantially equivalent to devices marketed prior to May 28, 1976. This type of letter does not contain the detailed information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a 510(k) summary.

Therefore, I cannot provide the requested information from this document. The letter itself is part of a regulatory process that determines marketability based on substantial equivalence to a predicate device, rather than a detailed performance study.

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