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U.S. FDA Medical Device ENT Wire Crimper 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 Wire Crimper companies with:

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