The following data is part of a premarket notification filed by Howmedica Leibinger, Inc. with the FDA for Cohen Distractor.
| Device ID | K972154 |
| 510k Number | K972154 |
| Device Name: | COHEN DISTRACTOR |
| Classification | Plate, Bone |
| Applicant | HOWMEDICA LEIBINGER, INC. 359 VETERANS BLVD. Rutherford, NJ 07070 |
| Contact | John F Dichiara |
| Correspondent | John F Dichiara HOWMEDICA LEIBINGER, 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 | 1997-06-09 |
| Decision Date | 1997-08-11 |
| Summary: | summary |