The following data is part of a premarket notification filed by Visitec Co. with the FDA for Pearce Corneal Trephine.
| Device ID | K812723 |
| 510k Number | K812723 |
| Device Name: | PEARCE CORNEAL TREPHINE |
| Classification | Trephine, Manual, Ophthalmic |
| Applicant | VISITEC CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HRH |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-09-28 |
| Decision Date | 1981-10-13 |