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U.S. FDA Medical Device Flexible Stone Dislodger Requirements


FDA Medical Device Definition: A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger.

Registrar Corp assists Flexible Stone Dislodger companies with:

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