The following data is part of a premarket notification filed by Visitec Co. with the FDA for Microsurgery Knife.
| Device ID | K820618 |
| 510k Number | K820618 |
| Device Name: | MICROSURGERY KNIFE |
| Classification | Knife, Ophthalmic |
| Applicant | VISITEC CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HNN |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-08 |
| Decision Date | 1982-04-09 |