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

BK180204: Royal MaxxPRP Concentration System

510(k) number: BK180204
Applicant: Royal Biologics, LLC
Device Name: Royal MaxxPRP Concentration System
Decision Date: 07/12/2018

Supporting Documents

BK180204 Letter
BK180204 Summary

Top