The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Drez Communicating Drill Guide.
| Device ID | K834350 |
| 510k Number | K834350 |
| Device Name: | ACUFEX DREZ COMMUNICATING DRILL GUIDE |
| Classification | Guide, Surgical, Instrument |
| Applicant | ACUFEX MICROSURGICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FZX |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-13 |
| Decision Date | 1984-03-19 |