The following data is part of a premarket notification filed by Cowellmedi Co., Ltd with the FDA for Cowell Implant System.
| Device ID | K100850 |
| 510k Number | K100850 |
| Device Name: | COWELL IMPLANT SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | COWELLMEDI CO., LTD 325 N. PUENTE ST UNIT B Brea, CA 92821 |
| Contact | Joyce Bang |
| Correspondent | Joyce Bang COWELLMEDI CO., LTD 325 N. PUENTE ST UNIT B Brea, CA 92821 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-26 |
| Decision Date | 2010-12-20 |
| Summary: | summary |