Table, Instrument, Manual, Ophthalmic

What Is FDA Product Code HRK?

Table, Instrument, Manual, Ophthalmic is FDA product code HRK, Class 1, 21 CFR 886.4855.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.