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Regulatory approvals

The DermaStream™ device has been FDA (510K) cleared in the United States of America with the following intended use:

"DermaStream is an occlusive dressing which permits the introduction of other topical wound treatments such as irrigation solutions, antimicrobial and enzymatic debriding solutions, suspensions, and other solutions. It is intended to provide a moist healing environment and to allow debridement to facilitate the normal wound healing process."

CE Mark for European sales is pending.
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