The following data is part of a premarket notification filed by Changzhou Waston Medical Appliance Co. Ltd with the FDA for Waston Metallic Bone Plate And Screw Systems.
| Device ID | K151057 |
| 510k Number | K151057 |
| Device Name: | WASTON Metallic Bone Plate And Screw Systems |
| Classification | Plate, Fixation, Bone |
| Applicant | CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD 9 Xihu Road, Wujin Hi-tech Industry Zone Changzhou, CN 213168 |
| Contact | Jack Lu |
| Correspondent | Diana Hong MID-LINK CONSULTING CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-20 |
| Decision Date | 2015-08-10 |
| Summary: | summary |