Barrier, Animal Source, Intraoral

Sk Bioland Co., Ltd.

The following data is part of a premarket notification filed by Sk Bioland Co., Ltd. with the FDA for Ossguide.

Pre-market Notification Details

Device IDK200623
510k NumberK200623
Device Name:OssGuide
ClassificationBarrier, Animal Source, Intraoral
Applicant Sk Bioland Co., Ltd. 162, Gwahaksaneop 3-ro, Ochang-eup, Cheongwon-gu Cheongju-si,  KR 28125
ContactYeonjeong Chae
CorrespondentSanglok Lee
WISE COMPANY Inc. RM #303, The Sky Balley-303, 142, Gasan Digital 1-Ro Geumcheon-gu,  KR 08507
Product CodeNPL  
CFR Regulation Number872.3930 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-09
Decision Date2020-10-02

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