The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Mitek Drill Guide.
| Device ID | K892904 |
| 510k Number | K892904 |
| Device Name: | MITEK DRILL GUIDE |
| Classification | Brace, Drill |
| Applicant | MITEK SURGICAL PRODUCTS, INC. 990 WASHINGTON ST. Dedham, MA 02026 |
| Contact | Robert P Zoletti |
| Correspondent | Robert P Zoletti MITEK SURGICAL PRODUCTS, INC. 990 WASHINGTON ST. Dedham, MA 02026 |
| Product Code | HXY |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-20 |
| Decision Date | 1989-09-28 |