What does 510 (k) mean?

What does 510 (k) mean?

Databases A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device…

Who is the owner of a 510k device?

The 510 (k) owner is the individual or firm that has legal authority to the device. Identify the person FDA should contact during the review process. A delay may occur if the FDA is not sure who to contact for additional information. Your establishment registration number.

What is a 510k premarket submission?

510(k) Premarket Notification. A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval.

What should the first page of a 510 (k) look like?

The first page of a 510 (k) should be a printed copy of the Medical Device User Fee Cover Sheet (Form FDA 3601). The Medical Device User Fee Cover Sheet and instructions are available online.