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U.S. FDA Medical Device Ophthalmic Spoon Requirements

FDA Medical Device Definition: A manual ophthalmic surgical instrument is a nonpowered, handheld device intended to aid or perform ophthalmic surgical procedures. This generic type of device includes the manual corneal burr, ophthalmic caliper, ophthalmic cannula, eyelid clamp, ophthalmic muscle clamp, iris retractor clip, orbital compressor, ophthalmic curette, cystotome, orbital depressor, lachrymal dilator, erisophake, expressor, ophthalmic forcep, ophthalmic hook, sphere introducer, ophthalmic knife, ophthalmic suturing needle, lachrymal probe, trabeculotomy probe, cornea-sclera punch, ophthalmic retractor, ophthalmic ring (Flieringa), lachrymal sac rongeur, ophthalmic scissors, enucleating snare, ophthalmic spatula, ophthalmic specula, ophthalmic spoon, ophthalmic spud, trabeculotome or ophthalmic manual trephine.

Registrar Corp assists Ophthalmic Spoon companies with:

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