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U.S. FDA Medical Device Ophthalmic Suturing Needle 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 Suturing Needle companies with:

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