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U.S. FDA Medical Device Nasopharyngeal Catheter Requirements


FDA Medical Device Definition: A nasopharyngeal catheter is a device consisting of a bougie or filiform catheter that is intended for use in probing or dilating the eustachian tube. This generic type of device includes eustachian catheters.

Registrar Corp assists Nasopharyngeal Catheter companies with:

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