The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for Chin Distractor.
| Device ID | K973484 |
| 510k Number | K973484 |
| Device Name: | CHIN DISTRACTOR |
| Classification | Plate, Bone |
| Applicant | HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Contact | John Dichiara |
| Correspondent | John Dichiara HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 -2584 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-15 |
| Decision Date | 1997-12-02 |
| Summary: | summary |