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U.S. FDA Medical Device Cast Removal Instrument Requirements


FDA Medical Device Definition: A cast removal instrument is an AC-powered, hand-held device intended to remove a cast from a patient. This generic type of device includes the electric cast cutter and cast vacuum.

Registrar Corp assists Cast Removal Instrument companies with:

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