Hello, I have a question that I’m hoping someone here can help me with. Our company wants to put a label onto a product made for us by the OEM. The product falls under Class II for the FDA and IIa within Europe. The OEM is the 510k holder and sells this product globally. Can our company apply labels that list us as the manufacturer and not mention anything about the OEM on it? The design, use and indications will remain the same. Any advice is appreciated. Thanks.