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U.S. FDA Medical Device Ophthalmic Eyelid Clamp 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 Eyelid Clamp companies with:

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