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U.S. FDA Medical Device Aqueous Shunt Requirements: Aqueous Shunt

FDA Medical Device Definition: An aqueous shunt is an implantable device intended to reduce intraocular pressure in the anterior chamber of the eye in patients with neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed

Registrar Corp assists Aqueous Shunt companies with:

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

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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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