The following data is part of a premarket notification filed by Mitek Surgical Products, Inc. with the FDA for Mitek Modular Drill Bit.
| Device ID | K935225 |
| 510k Number | K935225 |
| Device Name: | MITEK MODULAR DRILL BIT |
| Classification | Bit, Surgical |
| Applicant | MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood, MA 02062 |
| Contact | Robert Zoletti |
| Correspondent | Robert Zoletti MITEK SURGICAL PRODUCTS, INC. 57 PROVIDENCE HWY. Norwood, MA 02062 |
| Product Code | GFG |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-01 |
| Decision Date | 1994-04-07 |