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The HSW flexible nasopharyngoscope and accessories is a tubular endoscopic device and is intended to examine or treat the nasal cavity and nasal pharynx. This Nasopharyngoscope from HSW has been specially developed for use between the upper respiratory tracts of the nasal passage and the vocal chords, and may only be used for this purpose.

The HSW flexible nasopharyngoscope and accessories is a tubular endoscopic device.

This document is a 510(k) premarket notification letter from the FDA regarding a Nasopharyngoscope. It does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the format of AI/ML device performance.

The document primarily focuses on:

• Regulatory clearance: The FDA's determination that the Henke Sass Wolf of America Nasopharyngoscope is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
• Device classification: Class II, product code EOB.
• Intended use: To examine or treat the nasal cavity and nasal pharynx, specifically between the upper respiratory tracts of the nasal passage and the vocal cords.

Therefore, I cannot provide the requested table and study details as they are not present in the provided text. This type of information is typically found in accompanying technical documentation or clinical study reports, which are not included here.

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