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U.S. FDA Medical Device ENT Cutting Block Requirements

FDA Medical Device Definition: A prosthesis modification instrument for ossicular replacement surgery is a device intended for use by a surgeon to construct ossicular replacements. This generic type of device includes the ear, nose, and throat cutting block; wire crimper, wire bending die; wire closure forceps; piston cutting jib; gelfoamTMpunch; wire cutting scissors; and ossicular finger vise.

Registrar Corp assists ENT Cutting Block companies with:

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