How did you find out about USTR?

Please provide the FDA history of your device. Has an application been submitted? If so, when? If approved, what is the 510(k) or PMA number?

Company Name  
Address (Line 1)  
Address (Line 2)  
City  
State (Province)  
Postal (Zip) Code  
Country  
Year established  
# of employees  
     
Contact Name  
Position Title  
Telephone Number  
Fax Number  
Cell Phone  
Web Site  
E-mail  
     
Overview of the Product
Product Name  
Product is  
"substantially equivalent" to an existing product sold in the United States.
a "breakthrough technology".
I am not certain.

Is your product currently sold?
yes no

If "yes", in which country or countries?

What is the specific type of medical condition that would require the use of your product?

Please provide a general statement as to what your product does and how it works:

If your product is substantially equivalent to another FDA approved device, what are the advantages of yours compared to the competitor(s)?

USTR Services
Please check the boxes that represent areas of interest to your company.
Pre-Market Services:  
Coding Analysis Current Reimbursement Status
Coverage Analysis Competitor Market Analysis
Pricing Analysis Market Demographics
  Future Product Applications
FDA:  
510(k)  
PMA (Pre-Market Approval)
Post Market Services:  
Insurance Pricing  
Insurance Coding  
Insurance Coverage  
Other
# Projected Unit Sales:
Year 1 Year 2
Product Development Budget
Please check the box representing your company's budget for R&D.
$100,000-250,000 (USD)
$250,000-1,000,000 (USD)
$1,000,000 (USD) or more

Does you company sell any products at this time? If so, please complete the following.
Name of product Country # Units sold last year

 
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