The following data is part of a premarket notification filed by Microware Precision Co., Ltd. with the FDA for Microware Bone Plates And Bone Screw.
| Device ID | K111008 |
| 510k Number | K111008 |
| Device Name: | MICROWARE BONE PLATES AND BONE SCREW |
| Classification | Plate, Fixation, Bone |
| Applicant | MICROWARE PRECISION CO., LTD. NO. 12 KEYUAN 2ND RD. SITUN DISTRICT Taichung City, TW 40763 |
| Contact | Harrison Du |
| Correspondent | Harrison Du MICROWARE PRECISION CO., LTD. NO. 12 KEYUAN 2ND RD. SITUN DISTRICT Taichung City, TW 40763 |
| Product Code | HRS |
| Subsequent Product Code | HWC |
| Subsequent Product Code | KTT |
| Subsequent Product Code | NDG |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-11 |
| Decision Date | 2012-05-02 |
| Summary: | summary |