The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for Burr Hole Covers, Craniomaxillofacial Plates.
| Device ID | K983885 |
| 510k Number | K983885 |
| Device Name: | BURR HOLE COVERS, CRANIOMAXILLOFACIAL PLATES |
| Classification | Plate, Bone |
| Applicant | HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | Joseph Volpe |
| Correspondent | Joseph Volpe HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-02 |
| Decision Date | 1999-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04546540239464 | K983885 | 000 |
| 04546540239433 | K983885 | 000 |
| 04546540239419 | K983885 | 000 |
| 04546540238795 | K983885 | 000 |
| 04546540238788 | K983885 | 000 |
| 04546540238771 | K983885 | 000 |