The following data is part of a premarket notification filed by Kerrhawe Sa with the FDA for Compothixo.
| Device ID | K111465 |
| 510k Number | K111465 |
| Device Name: | COMPOTHIXO |
| Classification | Instruments, Dental Hand |
| Applicant | KERRHAWE SA 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Contact | Wendy Garman |
| Correspondent | Wendy Garman KERRHAWE SA 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Product Code | DZN |
| CFR Regulation Number | 872.4565 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-26 |
| Decision Date | 2012-07-25 |
| Summary: | summary |