The following data is part of a premarket notification filed by Osstem Implant Co.,ltd with the FDA for Gs Iii System.
| Device ID | K091208 |
| 510k Number | K091208 |
| Device Name: | GS III SYSTEM |
| Classification | Implant, Endosseous, Root-form |
| Applicant | OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
| Contact | Minjoo Kim |
| Correspondent | Minjoo Kim OSSTEM IMPLANT CO.,LTD 85 BEN FAIRLESS DR. Fairless Hills, PA 19030 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-24 |
| Decision Date | 2010-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800040630234 | K091208 | 000 |