The following data is part of a premarket notification filed by Diemolding Corp. with the FDA for Orthomix.
| Device ID | K760636 |
| 510k Number | K760636 |
| Device Name: | ORTHOMIX |
| Classification | Mixer, Cement, For Clinical Use |
| Applicant | DIEMOLDING CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JDZ |
| CFR Regulation Number | 888.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-09-13 |
| Decision Date | 1976-10-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ORTHOMIX 77497899 3675201 Live/Registered |
Helen Elaine Newman 2008-06-12 |
![]() ORTHOMIX 74292423 1991473 Dead/Cancelled |
Earle, Michael L. 1992-07-06 |