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U.S. FDA Medical Device Sterile Gustometer Requirements

FDA Medical Device Definition: A gustometer is a battery-powered device that consists of two electrodes that are intended to be placed on both sides of the tongue at different taste centers and that provides a galvanic stimulus resulting in taste sensation. It is used for assessing the sense of taste.

Registrar Corp assists Sterile Gustometer companies with:

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