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U.S. FDA Medical Device Keratoprosthesis Requirements: Keratoprosthesis

FDA Medical Device Definition: A keratoprosthesis is a device intended to provide a transparent optical pathway through an opacified cornea, either intraoperatively or permanently, in an eye that is not a reasonable candidate for a corneal transplant

Registrar Corp assists Keratoprosthesis companies with:

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