The following data is part of a premarket notification filed by Deknatel, Inc. with the FDA for Deknatel (r) Trephine.
| Device ID | K862524 |
| 510k Number | K862524 |
| Device Name: | DEKNATEL (R) TREPHINE |
| Classification | Trephine, Manual, Ophthalmic |
| Applicant | DEKNATEL, INC. 2300 MARCUS AVE. Lake Success, NY 11042 |
| Contact | Orofino |
| Correspondent | Orofino DEKNATEL, INC. 2300 MARCUS AVE. Lake Success, NY 11042 |
| Product Code | HRH |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-02 |
| Decision Date | 1986-08-11 |