Business Type null
Main Products
Country/Region United States
Company Introduction
A regulatory company that prepares forms 2891, 2891a, and 2892 on the behalf of foreign firms who are registering their medical devices or medical products with the FDA.
We submit 510(k) premarket notifications. We prepare
and/or submit the required reports to CDRH.
We serve as the legal correspondent between the foreign firms and the FDA. We maintain all files and the filing
of the necessary paperwork to FDA.
Contact Information
Contact Person Sharon Phillips
Job Title owner
Telephone 1 - 301 - 4283131
Address 13532 hamlet square court germantown md 20874 United States