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U.S. FDA Medical Device Bronchial Tube Requirements: Bronchial Tube

FDA Medical Device Definition: A bronchial tube is a device used to differentially intubate a patient's bronchus (one of the two main branches of the trachea leading directly to the lung) in order to isolate a portion of lung distal to the tube

Registrar Corp assists Bronchial Tube companies with:

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

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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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