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U.S. FDA Medical Device Bronchoscope (Flexible or Rigid) and Accessories Requirements: Bronchoscope (Flexible or Rigid) and Accessories

FDA Medical Device Definition: A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier

Registrar Corp assists Bronchoscope (Flexible or Rigid) and Accessories companies with:

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


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