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U.S. FDA Medical Device Stirrups Requirements

FDA Medical Device Definition: A urological table and accessories is a device that consists of a table, stirrups, and belts used to support a patient in a suitable position for endoscopic procedures of the lower urinary tract. The table can be adjusted into position manually or electrically.

Registrar Corp assists Stirrups companies with:

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