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U.S. FDA Medical Device Electrically Powered Saw 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 Electrically Powered Saw companies with:

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