The following data is part of a premarket notification filed by Innobiosurg Co., Ltd. with the FDA for Magicore Ii System.
Device ID | K192197 |
510k Number | K192197 |
Device Name: | Magicore II System |
Classification | Implant, Endosseous, Root-form |
Applicant | InnoBioSurg Co., Ltd. 44-19, Techno 10-ro, Yuseong-gu Daejeon, KR 34027 |
Contact | Eun-ji Yoo |
Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-08-13 |
Decision Date | 2020-04-28 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08800090601611 | K192197 | 000 |
08800039397025 | K192197 | 000 |
08800039396981 | K192197 | 000 |
08800039380188 | K192197 | 000 |
08800039371711 | K192197 | 000 |
08800039371650 | K192197 | 000 |
08800039371643 | K192197 | 000 |
08800090661332 | K192197 | 000 |
08800090661219 | K192197 | 000 |
08800090661165 | K192197 | 000 |
08800039397063 | K192197 | 000 |
08800039399319 | K192197 | 000 |
08800039399326 | K192197 | 000 |
08800090600034 | K192197 | 000 |
08800090600027 | K192197 | 000 |
08800039399395 | K192197 | 000 |
08800039399388 | K192197 | 000 |
08800039399371 | K192197 | 000 |
08800039399364 | K192197 | 000 |
08800039399357 | K192197 | 000 |
08800039399340 | K192197 | 000 |
08800039399333 | K192197 | 000 |
08800177388879 | K192197 | 000 |