The following data is part of a premarket notification filed by Kj Meditech Co., Ltd. with the FDA for Kj Mini Implant System.
Device ID | K151970 |
510k Number | K151970 |
Device Name: | KJ Mini Implant System |
Classification | Implant, Endosseous, Root-form |
Applicant | KJ MEDITECH CO., LTD. 959-21 DAECHON-DONG, BUK-GU Gwang-ju, KR 959-21 |
Contact | Goong-san Nam |
Correspondent | Priscilla Chung LK CONSULTING GROUP USA, INC. 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92831 |
Product Code | DZE |
CFR Regulation Number | 872.3640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-16 |
Decision Date | 2016-10-21 |
Summary: | summary |