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U.S. FDA Medical Device Nonpneumatic 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 Nonpneumatic Tourniquet companies with:

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