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U.S. FDA Medical Device Gastro-Urology Tourniquet Requirements


FDA Medical Device Definition: A nonpneumatic tourniquet is a device consisting of a strap or tubing intended to be wrapped around a patient's limb and tightened to reduce circulation.

Registrar Corp assists Gastro-Urology Tourniquet companies with:

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