The following data is part of a premarket notification filed by Eye-ko, Inc. with the FDA for Disposal Surgical Instruments For Ophthalmology.
| Device ID | K864292 |
| 510k Number | K864292 |
| Device Name: | DISPOSAL SURGICAL INSTRUMENTS FOR OPHTHALMOLOGY |
| Classification | Hook, Ophthalmic |
| Applicant | EYE-KO, INC. P.O. BOX 1632 West Chester, PA 19380 |
| Contact | Gregory L Beinecke |
| Correspondent | Gregory L Beinecke EYE-KO, INC. P.O. BOX 1632 West Chester, PA 19380 |
| Product Code | HNQ |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-31 |
| Decision Date | 1986-12-29 |