The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex T-fix Delivery System.
| Device ID | K942442 |
| 510k Number | K942442 |
| Device Name: | ACUFEX T-FIX DELIVERY SYSTEM |
| Classification | Needle, Spinal, Short Term |
| Applicant | ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Frederick Tobia |
| Correspondent | Frederick Tobia ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | MIA |
| CFR Regulation Number | 868.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-23 |
| Decision Date | 1994-12-05 |