My firm manufactures and distributes several of our own Class II medical devices. We would now like to import a class II device from an overseas manufacturer who is registered with the FDA and has a 510(k) for the device. We then want to relabel the product with our own label (with basic company name and item name information), and market the product as our own device. The overseas manufacturer is fine with this. But, would we need to get a 510(k) for the product, or just list it with our other device listings?