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U.S. FDA Medical Device Culdoscope & Accessories Requirements


FDA Medical Device Definition: A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.

Registrar Corp assists Culdoscope & Accessories companies with:

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