The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Sub-acromial Space Measuring Device.
| Device ID | K940480 |
| 510k Number | K940480 |
| Device Name: | ACUFEX SUB-ACROMIAL SPACE MEASURING DEVICE |
| Classification | Gauge, Depth |
| 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 | HTJ |
| CFR Regulation Number | 888.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-02 |
| Decision Date | 1994-03-23 |