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U.S. FDA Medical Device Esophageal Prosthesis Requirements: Esophageal Prosthesis

FDA Medical Device Definition: An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system

Registrar Corp assists Esophageal Prosthesis companies with:

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