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

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