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OTC - Hypo Clenz Wound & Skin Wash is intended for OTC use for the mechanical cleansing (irrigation) of material from minor cuts, minor burns, minor lacerations, minor skin abrasions, minor skin irritations and intact skin.
Professional - Hypo Clenz Antimicrobial Wound & Skin Wash is intended to be used by health care professionals in the management of wounds such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites.

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I am sorry but this document does not contain the information you are requesting. This document is a 510(k) premarket notification decision letter from the FDA to Nevoa Life Sciences, LLC, regarding their device "Hypo Clenz Antimicrobial Wound & Skin Wash".

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It also outlines regulatory requirements such as annual registration, labeling, and good manufacturing practices. The "Indications for Use" enclosure describes the intended uses of the device for both over-the-counter and professional use, primarily for cleansing and irrigating wounds and skin.

It does not include any information about acceptance criteria, study data, sample sizes, ground truth establishment, or multi-reader multi-case studies as these are typically found in the 510(k) summary or the full submission, not in the decision letter itself.

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