IBS Implant System

Implant, Endosseous, Root-form

InnoBioSurg Co., Ltd.

The following data is part of a premarket notification filed by Innobiosurg Co., Ltd. with the FDA for Ibs Implant System.

Pre-market Notification Details

Device IDK202479
510k NumberK202479
Device Name:IBS Implant System
ClassificationImplant, Endosseous, Root-form
Applicant InnoBioSurg Co., Ltd. 44-19, Techno 10-ro, Yuseong-gu Daejeon,  KR 34027
ContactBo-yeon Lim
CorrespondentApril Lee
Withus Group Inc 106 Superior Irvine,  CA  92620
Product CodeDZE  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-28
Decision Date2020-09-23

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.