The following data is part of a premarket notification filed by Xiamen Double Engine Medical Material Co., Ltd with the FDA for Double Engine Bone Plate And Screw Systems.
Device ID | K130108 |
510k Number | K130108 |
Device Name: | DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS |
Classification | Plate, Fixation, Bone |
Applicant | XIAMEN DOUBLE ENGINE MEDICAL MATERIAL CO., LTD NO. 218, HOUXIANG ROAD HAICANG DISTRICT Xiamen, CN 361022 |
Contact | Da Zeng |
Correspondent | Da Zeng XIAMEN DOUBLE ENGINE MEDICAL MATERIAL CO., LTD NO. 218, HOUXIANG ROAD HAICANG DISTRICT Xiamen, CN 361022 |
Product Code | HRS |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-01-16 |
Decision Date | 2013-04-19 |
Summary: | summary |