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US FDA 510k Submission Cost

Guidance, 510(k) Prepration, US Agent, Pre-Submission and Submission

The high quality time bound service from I 3 CONSULTING always comes with very economic pricing. You may surprce how this is possible while others are charging 3 times to 5 times more!!!. The main reason for the economic pricing is we hand over the project to our India office where the qualified pool of consultants work for your 510k file.

Please check our pricing / 510k Fees. here

If you are looking for GMP /Medical Device 21  CFR 820  related fees, Click Here

We have package fees and individual service fees. The package fees covers the following:

  • 510k Guidance & prepration Fees
  • Pr-Submission & Final Submission Fees
  • US Agent Fees
  • 21 CFR 820 Implementation Fees
  • Establishment Registration & Device Listing Fees
  • Support during FDA auditors Fees
  • Post audit support for closing NC/483 Fees

Please contact us for quick information.

INDIA -Bangalore
+ 91 994 591 2081
Phone / WhatsApp


USA -Chicago
+1 630 696 1293
Phone / WhatsApp


GERMANY-Bremen
+49 2161 990 8831
Phone / WhatsApp

enquiry@i3cglobal.com

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