The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Fixation Button; Retention Bar, Wedge.
| Device ID | K896310 |
| 510k Number | K896310 |
| Device Name: | ACUFEX FIXATION BUTTON; RETENTION BAR, WEDGE |
| Classification | Retention Device, Suture |
| Applicant | ACUFEX MICROSURGICAL, INC. 575 UNIVERSITY AVE. Norwood, MA 02062 |
| Contact | Richard E Franko |
| Correspondent | Richard E Franko ACUFEX MICROSURGICAL, INC. 575 UNIVERSITY AVE. Norwood, MA 02062 |
| Product Code | KGS |
| CFR Regulation Number | 878.4930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-01 |
| Decision Date | 1989-11-20 |