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U.S. FDA Medical Device Patient Personal Hygiene Kit Requirements


FDA Medical Device Definition: A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.

Registrar Corp assists Patient Personal Hygiene Kit companies with:

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