The following data is part of a premarket notification filed by Cowell Medi Co Ltd. with the FDA for Bio Plant System (implants And Abutments).
| Device ID | K041655 |
| 510k Number | K041655 |
| Device Name: | BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS) |
| Classification | Implant, Endosseous, Root-form |
| Applicant | COWELL MEDI CO LTD. 161 LITTLE BAY ROAD Newington, NH 03801 |
| Contact | Dae Kyu Chang |
| Correspondent | Dae Kyu Chang COWELL MEDI CO LTD. 161 LITTLE BAY ROAD Newington, NH 03801 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-18 |
| Decision Date | 2004-09-08 |
| Summary: | summary |