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U.S. FDA Medical Device Skull Punch Requirements

FDA Medical Device Definition: A skull punch is a device used to punch holes through a patient's skull to allow fixation of cranioplasty plates or bone flaps by wire or other means

Registrar Corp assists Skull Punch companies with:

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