The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex T-fix Rotator Cuff Guide Systems.
| Device ID | K941364 |
| 510k Number | K941364 |
| Device Name: | ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS |
| Classification | Arthroscope |
| 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 | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-21 |
| Decision Date | 1994-05-16 |