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

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