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U.S. FDA Medical Device Powered Saw & Accessories 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 Powered Saw & Accessories companies with:

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