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U.S. FDA Medical Device Tuning Fork Requirements

FDA Medical Device Definition: A tuning fork is a mechanical device which resonates at a given frequency and is used to diagnose hearing disorders and to test for vibratory sense.

Registrar Corp assists Tuning Fork companies with:

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

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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