The following data is part of a premarket notification filed by Howmedica Leibinger, Inc. with the FDA for Epitec Titanium Implant System For The Surgical Anchoring Of Facial Prostheses.
| Device ID | K961719 |
| 510k Number | K961719 |
| Device Name: | EPITEC TITANIUM IMPLANT SYSTEM FOR THE SURGICAL ANCHORING OF FACIAL PROSTHESES |
| Classification | Plate, Fixation, Bone |
| Applicant | HOWMEDICA LEIBINGER, INC. 14540 BELTWOOD PARKWAY EAST Dallas, TX 75244 |
| Contact | Andrew B Rogers |
| Correspondent | Andrew B Rogers HOWMEDICA LEIBINGER, INC. 14540 BELTWOOD PARKWAY EAST Dallas, TX 75244 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-02 |
| Decision Date | 1997-07-17 |
| Summary: | summary |