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U.S. FDA Medical Device Lachrymal Sac Rongeur 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 Lachrymal Sac Rongeur companies with:

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