PART #860070 ULTRAPAK & #860075 ULTRAPAK
Device Facts
| Record ID | K871474 |
|---|---|
| Device Name | PART #860070 ULTRAPAK & #860075 ULTRAPAK |
| Applicant | Medical Technical Products |
| Product Code | HOC · Ophthalmic |
| Decision Date | Aug 10, 1987 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4350 |
| Device Class | Class 1 |
Regulatory Classification
Identification
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.
