The following data is part of a premarket notification filed by Cowellmedi Co., Ltd with the FDA for Atlas Implant System - Wide Plus.
| Device ID | K090054 |
| 510k Number | K090054 |
| Device Name: | ATLAS IMPLANT SYSTEM - WIDE PLUS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | COWELLMEDI CO., LTD 13340 E. FIRESTONE BLVD. SUITE J Santa Fe Springs, CA 90670 |
| Contact | Jung Bae Bang |
| Correspondent | Jung Bae Bang COWELLMEDI CO., LTD 13340 E. FIRESTONE BLVD. SUITE 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 | 2009-01-08 |
| Decision Date | 2009-07-29 |
| Summary: | summary |