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U.S. FDA Medical Device Ophthalmic Rotary Prism Requirements


FDA Medical Device Definition: An ophthalmic rotary prism is a device with various prismatic powers intended to be handheld and used to measure ocular deviation in patients with latent or manifest strabismus (eye muscle deviation).

Registrar Corp assists Ophthalmic Rotary Prism companies with:

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