(76 days)
The Hydrogel dressing is intended for use to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment around the wound. The dressing is appropriate applied to the following indications: minor cuts, minor lacerations. Under the guidance of a health professional the hydrogel dressing is also indicated for surgical incisions and excisions, venous stasis ulcers and decubitus ulcers.
Dumex Pak-its Cotton Gauze Packing Impregnated with Hydrogel
This document is a 510(k) clearance letter from the FDA for the "Dumex Pak-its Cotton Gauze Packing Impregnated with Hydrogel". It is a regulatory document and does not contain information about acceptance criteria or a study proving device performance as requested.
The letter approves the marketing of the device based on its substantial equivalence to a predicate device, and it outlines limitations on labeling and claims. It does not provide details of clinical trials, performance studies, or the specific criteria used to evaluate the device's efficacy or safety.
Therefore, I cannot fulfill the request for information regarding acceptance criteria and study details based on the provided text.
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