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U.S. FDA Medical Device Microsurgical Instrument Requirements


FDA Medical Device Definition: A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures.

Registrar Corp assists Microsurgical Instrument companies with:

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