The following data is part of a premarket notification filed by Intl. Ophthalmic Industries Corp. with the FDA for (micro-keratron, Micro Duct Trephine).
| Device ID | K791763 |
| 510k Number | K791763 |
| Device Name: | (MICRO-KERATRON, MICRO DUCT TREPHINE) |
| Classification | Engine, Trephine, Accessories, Ac-powered |
| Applicant | INTL. OPHTHALMIC INDUSTRIES CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HRG |
| CFR Regulation Number | 886.4070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-09-05 |
| Decision Date | 1979-11-05 |