The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex T-bar.
| Device ID | K925573 |
| 510k Number | K925573 |
| Device Name: | ACUFEX T-BAR |
| 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 | 1992-11-03 |
| Decision Date | 1993-05-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03596010446114 | K925573 | 000 |
| 03596010420879 | K925573 | 000 |
| 03596010026934 | K925573 | 000 |
| 03596010026927 | K925573 | 000 |
| 03596010026910 | K925573 | 000 |
| 03596010026279 | K925573 | 000 |
| 23596010026099 | K925573 | 000 |
| 00885554009156 | K925573 | 000 |