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U.S. FDA Medical Device Cement Dispenser Requirements

FDA Medical Device Definition: A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (888.3027) into surgical sites.

Registrar Corp assists Cement Dispenser companies with:

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