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U.S. FDA Medical Device Sterile Gelfoam Punch 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 Sterile Gelfoam Punch companies with:

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