The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Intra Articular Measuring Device.
| Device ID | K925335 |
| 510k Number | K925335 |
| Device Name: | ACUFEX INTRA ARTICULAR MEASURING DEVICE |
| Classification | Gauge, Depth |
| Applicant | ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Llynne Aronson |
| Correspondent | Llynne Aronson ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | HTJ |
| CFR Regulation Number | 888.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-22 |
| Decision Date | 1992-12-29 |