The following data is part of a premarket notification filed by Cher Mel Corp. with the FDA for Chermel Osteotomes.
| Device ID | K842823 |
| 510k Number | K842823 |
| Device Name: | CHERMEL OSTEOTOMES |
| Classification | Osteotome, Manual |
| Applicant | CHER MEL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GFI |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-19 |
| Decision Date | 1984-08-02 |