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

FDA Medical Device Definition: An ear prosthesis is a silicone rubber solid device intended to be implanted to reconstruct the external ear

Registrar Corp assists Ear Prosthesis companies with:

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