The following data is part of a premarket notification filed by Microware Precision Co., Ltd. with the FDA for Tandry Cmf Plate System.
| Device ID | K220360 |
| 510k Number | K220360 |
| Device Name: | Tandry CMF Plate System |
| Classification | Plate, Bone |
| Applicant | Microware Precision Co., Ltd. No. 12, Keyuan 2nd Rd., Situn District Taichung, TW 40763 |
| Contact | Harrison Du |
| Correspondent | Harrison Du Microware Precision Co., Ltd. No. 12, Keyuan 2nd Rd., Situn District Taichung, TW 40763 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-08 |
| Decision Date | 2022-11-10 |