The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for Luhr(r) Titanium Burr Hole Covers.
| Device ID | K950115 |
| 510k Number | K950115 |
| Device Name: | LUHR(R) TITANIUM BURR HOLE COVERS |
| Classification | Plate, Fixation, Bone |
| Applicant | HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Contact | John F Dichiara |
| Correspondent | John F Dichiara HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-11 |
| Decision Date | 1995-04-10 |