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U.S. FDA Medical Device Ophthalmic Fresnel Prism Requirements


FDA Medical Device Definition: An ophthalmic Fresnel prism is a device that is a thin plastic sheet with embossed rulings which provides the optical effect of a prism. The device is intended to be applied to spectacle lenses to give a prismatic effect.

Registrar Corp assists Ophthalmic Fresnel Prism companies with:

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