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U.S. FDA Medical Device Dermatome 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 Dermatome companies with:

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