An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

In this section: Substantially Equivalent 510(k) Device Information

BK200456 - GeTraP

510(k) Number: BK200456
Applicant: Kedrion SpA
Device Name: GeTraP
Decision Date: 4/20/2020

Supporting Documents

BK200456 Letter
510(k) Statement

Top