The following data is part of a premarket notification filed by Innobiosurg Co., Ltd. with the FDA for Magicore System.
Device ID | K212517 |
510k Number | K212517 |
Device Name: | Magicore System |
Classification | Implant, Endosseous, Root-form |
Applicant | InnoBioSurg Co., Ltd. 44-19, Techno 10-ro, Yuseong-gu Daejeon, KR 34027 |
Contact | Jonghyuk Seo |
Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-08-10 |
Decision Date | 2021-10-15 |