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