The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acuflex Disposable Knives.
| Device ID | K933921 |
| 510k Number | K933921 |
| Device Name: | ACUFLEX DISPOSABLE KNIVES |
| Classification | Knife, Orthopedic |
| 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 | HTS |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-10 |
| Decision Date | 1994-01-26 |