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We are manufacturing ptosis sling. It is used to repair eye lid.
We would like to get 510(K) for this product. We understood from FDA website that BD Ophthalmic system had got and their number is K942402. But database haven't showed the details. Kindly help me to locate the details.
[FONT=verdana,arial]What is 510(K) exempt? Is it meant there is no need to apply for 510(K). Kindly clarify.[/FONT]
Usha
We would like to get 510(K) for this product. We understood from FDA website that BD Ophthalmic system had got and their number is K942402. But database haven't showed the details. Kindly help me to locate the details.
[FONT=verdana,arial]What is 510(K) exempt? Is it meant there is no need to apply for 510(K). Kindly clarify.[/FONT]
Usha