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U.S. FDA Medical Device Fluid Evacuator System Requirements


FDA Medical Device Definition: A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered bladder evacuator, and the AC-powered vacuum pump.

Registrar Corp assists Fluid Evacuator System companies with:

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