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U.S. FDA Medical Device Dura Substitute Requirements: Dura Substitute

FDA Medical Device Definition: A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain)

Registrar Corp assists Dura Substitute companies with:

  • FDA Dura Substitute Establishment Registration
  • FDA Dura Substitute Listing
  • FDA Dura Substitute Label Requirements and Exceptions
  • FDA Dura Substitute Import Information
  • FDA Dura Substitute Detentions (Dura Substitute Entry Refusals)
  • General U.S. Food and Drug Administration Medical Device Guidelines for:
       - Dura Substitute Manufacturers (Dura Substitute Suppliers)
       - Dura Substitute Distributors
       - Dura Substitute Processors
       - Dura Substitute Repackers
       - Dura Substitute Relabelers
       - Dura Substitute Exporters
       - Dura Substitute Importers
For more information about Dura Substitute Medical Devices, simply click below:

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U.S. FDA Regulations:

U.S. FDA 510(k) Regulation: 21 C.F.R. section 814.9.

Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
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