The following data is part of a premarket notification filed by Acufex Microsurgical, Inc. with the FDA for Acufex Endofix Button.
| Device ID | K922559 |
| 510k Number | K922559 |
| Device Name: | ACUFEX ENDOFIX BUTTON |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Contact | Jeffrey E Henderson |
| Correspondent | Jeffrey E Henderson ACUFEX MICROSURGICAL, INC. 130 FORBES BLVD. Mansfield, MA 02048 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-29 |
| Decision Date | 1992-12-24 |