OssGuide

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 ID: K200623
• 510k Number: K200623
• Device Name: OssGuide
• Classification: Barrier, Animal Source, Intraoral
• Applicant: Sk Bioland Co., Ltd. 162, Gwahaksaneop 3-ro, Ochang-eup, Cheongwon-gu Cheongju-si, KR 28125
• Contact: Yeonjeong Chae
• Correspondent: Sanglok Lee; WISE COMPANY Inc. RM #303, The Sky Balley-303, 142, Gasan Digital 1-Ro Geumcheon-gu, KR 08507
• Product Code: NPL
• CFR Regulation Number: 872.3930 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-03-09
• Decision Date: 2020-10-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08800048502083	K200623	000
08800048502359	K200623	000
08800048502342	K200623	000
08800048502526	K200623	000
08800048502519	K200623	000
08800048502502	K200623	000
08800048502915	K200623	000
08800048502908	K200623	000
08800048502892	K200623	000
D767C0703010	K200623	000
D767C0702010	K200623	000
08800048502366	K200623	000
08800048502373	K200623	000
08800048502380	K200623	000
08800048502076	K200623	000
08800048502069	K200623	000
08800048502052	K200623	000
08800048502045	K200623	000
08800048502182	K200623	000
08800048502175	K200623	000
08800048502168	K200623	000
08800048502250	K200623	000
08800048502243	K200623	000
08800048502236	K200623	000
D767C0701010	K200623	000