The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Sterile Drills.
| Device ID | K931837 |
| 510k Number | K931837 |
| Device Name: | ACUFEX STERILE DRILLS |
| Classification | Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment |
| Applicant | ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Lynne Aronson |
| Correspondent | Lynne Aronson ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | HWE |
| CFR Regulation Number | 878.4820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-13 |
| Decision Date | 1994-01-07 |