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 |