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U.S. FDA Medical Device Crimp Plier Requirements

FDA Medical Device Definition: A blood access device and accessories is a device intended to provide access to a patient's blood for hemodialysis or other chronic uses. When used in hemodialysis, it is part of an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and provides access to a patient's blood for hemodialysis. The device includes implanted blood access devices, nonimplanted blood access devices, and accessories for both the implanted and nonimplanted blood access devices.

Registrar Corp assists Crimp Plier companies with:

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