Band-aids with Neosporin bandages (the band-aids that come with the Neosporin already applied) are a combination product. It’s primary mode is it protects your wound and also helps treat it. This would be under the CDRH because it is first a medical device and it would be class 1. The regulatory pathway would be like the one outlined on slide 31. The pathway in chronological order is RFD and then 510(k). Its a combination product so it would need an RFD but its also a class 1 device under the CDRH so a 510(k) would be needed.