regulatory help.com
- Business Type : null
- Main Products :
- Country/Region : United States
- Links : United States Business Services, United States Other Business Services,
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
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