(63 days)
The "AbsorbaSalt" Cotton Gauze Packing is a dry dressing impregnated with crystalline seawater salt that is intended for use on moderately to heavily exudating wounds. The dressing will Sur that is mondou for act on moist hypertonic environment when applied to a wound. A moist wound environment will support autolytic debridement of the dressing is appropriate would offications will our cuts, minor burns and minor lacerations. Under the guidance for the following multions: himor outs, rather attern Gauze Packing is also indicated for surgical incisions and excisions, venous stasis ulcers, pressure ulcers and decubitus ulcers.
The "AbsorbaSalt" Cotton Gauze Packing is a dry dressing impregnated with crystalline seawater salt.
This document is a 510(k) clearance letter from the FDA for a medical device called "Dumex Pak-its 'AbsorbaSalt' Cotton Gauze Packing." It states that the device is substantially equivalent to legally marketed predicate devices. However, the letter does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
Therefore, I cannot provide the requested information. The document primarily focuses on regulatory clearance and limitations on labeling claims rather than detailed performance study results.
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