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Global DMSO Blastocyst Vitrification Kit:

• Intended for the vitrification (ultra-rapid freezing) and cryostorage of . human blastocysts.
  Global DMSQ Blastocyst Vitrification Warming Kit
• . Intended for the recovery and rehydration of vitrified human blastocysts
• Intended for use with blastocysts that have been vitrified using the Global . DMSO Blastocyst Vitrification Kit.

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The provided text is a letter from the FDA regarding a 510(k) premarket notification for two devices: the "Global DMSO Blastocyst Vitrification Kit" and the "Global DMSO Blastocyst Vitrification Warming Kit." This document does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The letter is primarily an approval notice, stating that the FDA has determined the devices are "substantially equivalent" to legally marketed predicate devices. It outlines regulatory requirements and general information but does not delve into the specific performance data or studies that would typically be included in a 510(k) submission itself.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study based on the provided input. The necessary information is not present in this document.

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