FDAnews
www.fdanews.com/articles/110708-i-flow-nbsp-receives-fda-510-k-clearance-for-wound-dressing

I-Flow Receives FDA 510(k) Clearance for Wound Dressing

September 25, 2008
The FDA granted 510(k) clearance to I-Flow Corp. for its oxygen-enriched topical wound dressing. The product supplies oxygen and manages moisture in difficult-to-heal wounds. It is topically applied to burns and acute and chronic wounds and may be ideal for patients who might benefit from supplemental oxygen but who do not have access to hyperbaric oxygen, I-Flow said. Patents for the product have been issued in the U.S. and Europe.