The following data is part of a premarket notification filed by Canica Design, Inc. with the FDA for Chess Hand Surgery System.
| Device ID | K010184 |
| 510k Number | K010184 |
| Device Name: | CHESS HAND SURGERY SYSTEM |
| Classification | Instrument, Manual, Surgical, General Use |
| Applicant | CANICA DESIGN, INC. 36 MILL ST. Almonte, Ontario, CA Koa1ao |
| Contact | Georgette Roy |
| Correspondent | Georgette Roy CANICA DESIGN, INC. 36 MILL ST. Almonte, Ontario, CA Koa1ao |
| Product Code | MDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-19 |
| Decision Date | 2001-06-22 |