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U.S. FDA Medical Device Surgical Bur Requirements

FDA Medical Device Definition: Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Registrar Corp assists Surgical Bur companies with:

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