The following data is part of a premarket notification filed by Techno Ophthalmics Intl. with the FDA for Ophthalmic Surgical Instruments.
| Device ID | K864183 |
| 510k Number | K864183 |
| Device Name: | OPHTHALMIC SURGICAL INSTRUMENTS |
| Classification | Forceps, Ophthalmic |
| Applicant | TECHNO OPHTHALMICS INTL. 15A MARCONI ST. Irvine, CA 92718 |
| Contact | S. K Mcgarvey |
| Correspondent | S. K Mcgarvey TECHNO OPHTHALMICS INTL. 15A MARCONI ST. Irvine, CA 92718 |
| Product Code | HNR |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-27 |
| Decision Date | 1986-11-28 |