The following data is part of a premarket notification filed by Implant Innovations, Inc. with the FDA for Osseotite Iol Implants And Osseotite Certain Iol Implants.
| Device ID | K031632 |
| 510k Number | K031632 |
| Device Name: | OSSEOTITE IOL IMPLANTS AND OSSEOTITE CERTAIN IOL IMPLANTS |
| Classification | Implant, Endosseous, Root-form |
| Applicant | IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Contact | Jacquelyn A Hughes, Rac |
| Correspondent | Jacquelyn A Hughes, Rac IMPLANT INNOVATIONS, INC. 4555 RIVERSIDE DR. Palm Beach Gardens, FL 33410 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-27 |
| Decision Date | 2003-09-16 |
| Summary: | summary |