The following data is part of a premarket notification filed by Microptics Development Laboratory with the FDA for Ophthalmic Knife.
| Device ID | K922378 |
| 510k Number | K922378 |
| Device Name: | OPHTHALMIC KNIFE |
| Classification | Knife, Ophthalmic |
| Applicant | MICROPTICS DEVELOPMENT LABORATORY 3855 BIRCH ST. Newport Beach, CA 92660 |
| Contact | Mark Steen |
| Correspondent | Mark Steen MICROPTICS DEVELOPMENT LABORATORY 3855 BIRCH ST. Newport Beach, CA 92660 |
| Product Code | HNN |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-20 |
| Decision Date | 1992-12-10 |