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U.S. FDA Medical Device Manual Ophthalmic Chair Requirements


FDA Medical Device Definition: An ophthalmic chair is an AC-powered or manual device with adjustable positioning in which a patient is to sit or recline during ophthalmological examination or treatment.

Registrar Corp assists Manual Ophthalmic Chair companies with:

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