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U.S. FDA Medical Device Keratome Requirements: Keratome

FDA Medical Device Definition: A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant

Registrar Corp assists Keratome companies with:

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