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Hi everyone.
There's this situation where a company has 2 physically similar products, a normal and advanced one. The advanced one has 510k number but not the normal one. However, the client wants to import the normal one to USA. Can the company use the advanced's 510k number? The material and intended purpose are the same. It's just the advanced one was safe from a more hazardous chemical.
Thank you
There's this situation where a company has 2 physically similar products, a normal and advanced one. The advanced one has 510k number but not the normal one. However, the client wants to import the normal one to USA. Can the company use the advanced's 510k number? The material and intended purpose are the same. It's just the advanced one was safe from a more hazardous chemical.
Thank you