The following data is part of a premarket notification filed by Midwest Implant Sales, Inc. with the FDA for Midwest Implant Hexed 3.3 Mm Cylinder Type Implant.
| Device ID | K914041 |
| 510k Number | K914041 |
| Device Name: | MIDWEST IMPLANT HEXED 3.3 MM CYLINDER TYPE IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | MIDWEST IMPLANT SALES, INC. P.O. BOX 681038 Schaumburg, IL 60168 |
| Contact | John T Corsten |
| Correspondent | John T Corsten MIDWEST IMPLANT SALES, INC. P.O. BOX 681038 Schaumburg, IL 60168 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-10 |
| Decision Date | 1991-12-09 |