The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Surgical Retention Bar.
| Device ID | K902001 |
| 510k Number | K902001 |
| Device Name: | SURGICAL RETENTION BAR |
| 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 | 1990-05-02 |
| Decision Date | 1990-05-09 |