The following data is part of a premarket notification filed by Walter Abendschein, M.d. with the FDA for Cod Compression Osteotomy Device.
| Device ID | K002184 |
| 510k Number | K002184 |
| Device Name: | COD COMPRESSION OSTEOTOMY DEVICE |
| Classification | Plate, Fixation, Bone |
| Applicant | WALTER ABENDSCHEIN, M.D. 5530 WISCONSIN AVE. SUITE 705 Chevy Chase, MD 20815 |
| Contact | Walter Abendschein |
| Correspondent | Walter Abendschein WALTER ABENDSCHEIN, M.D. 5530 WISCONSIN AVE. SUITE 705 Chevy Chase, MD 20815 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-19 |
| Decision Date | 2000-11-24 |