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U.S. FDA Medical Device Epistaxis Balloon Requirements

FDA Medical Device Definition: An epistaxis balloon is a device consisting of an inflatable balloon intended to control internal nasal bleeding by exerting pressure against the sphenopalatine artery.

Registrar Corp assists Epistaxis Balloon companies with:

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