The following data is part of a premarket notification filed by Cowell Medi Co Ltd. with the FDA for Allfim Implant Systems.
| Device ID | K050635 |
| 510k Number | K050635 |
| Device Name: | ALLFIM IMPLANT SYSTEMS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | COWELL MEDI CO LTD. 13340 E. FIRESTONE BLVD. SUITES J Santa Fe Springs, CA 90670 |
| Contact | Dae Kyu Chang |
| Correspondent | Dae Kyu Chang COWELL MEDI CO LTD. 13340 E. FIRESTONE BLVD. SUITES J Santa Fe Springs, CA 90670 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-31 |
| Decision Date | 2005-07-28 |
| Summary: | summary |