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U.S. FDA Medical Device Chisel (Osteotome) 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 Chisel (Osteotome) companies with:

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