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The Thalafix Natural Sea-Salt Dressing is a dry dressing impregnated with crystalline seawater salt that is intended for use on moderately to heavily exudating wounds. The dressing will absorb exudate and maintain a moist hypertonic environment when applied to a wound. A moist wound environment will support autolytic debridement of the wound. The dressing is appropriate for the following indications: minor cuts, minor burns and minor lacerations. Under the guidance of a health care professional, the Thalafix Natural Sea-Salt Dressing is also indicated for surgical incisions and excisions, venous stasis ulcers, pressure ulcers and decubitus ulcers.

The Thalafix Natural Sea-Salt Dressing is a dry dressing impregnated with crystalline seawater salt.

This document is an FDA 510(k) clearance letter for a medical device called "Thalafix Natural Sea Salt Dressing." It does not contain information about acceptance criteria, device performance, or a study proving the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to a predicate device and outlines specific labeling limitations.

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