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U.S. FDA Medical Device Disconnect Forceps 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 Disconnect Forceps companies with:

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