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 |