The following data is part of a premarket notification filed by Jeil Medical Corporation with the FDA for Dual Top Anchor System Screws.
| Device ID | K033767 |
| 510k Number | K033767 |
| Device Name: | DUAL TOP ANCHOR SYSTEM SCREWS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | JEIL MEDICAL CORPORATION PO BOX 7007 Deerfiled, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm JEIL MEDICAL CORPORATION PO BOX 7007 Deerfiled, IL 60015 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-03 |
| Decision Date | 2004-02-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809265157328 | K033767 | 000 |
| 08809265156284 | K033767 | 000 |
| 08809265156789 | K033767 | 000 |
| 08809265156796 | K033767 | 000 |
| 08806390805322 | K033767 | 000 |
| 08809265156277 | K033767 | 000 |
| 08809265156291 | K033767 | 000 |
| 08809265156802 | K033767 | 000 |
| 08809265156819 | K033767 | 000 |
| 08809265157304 | K033767 | 000 |
| 08809265157311 | K033767 | 000 |
| 00885797100290 | K033767 | 000 |