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U.S. FDA Medical Device Gonioscopic Prism Requirements

FDA Medical Device Definition: A gonioscopic prism is a device that is a prism intended to be placed on the eye to study the anterior chamber. The device may have angled mirrors to facilitate visualization of anatomical features.

Registrar Corp assists Gonioscopic Prism companies with:

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