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 |
| 08800048502519 | K200623 | 000 |
| 08800048502526 | K200623 | 000 |
| 08800048502342 | K200623 | 000 |
| 08800048502359 | K200623 | 000 |
| 08800048502366 | K200623 | 000 |
| 08800048502373 | K200623 | 000 |
| 08800048502380 | K200623 | 000 |
| 08800048502236 | K200623 | 000 |
| 08800048502243 | K200623 | 000 |
| 08800048502250 | K200623 | 000 |
| 08800048502168 | K200623 | 000 |
| 08800048502175 | K200623 | 000 |
| 08800048502182 | K200623 | 000 |
| 08800048502045 | K200623 | 000 |
| 08800048502052 | K200623 | 000 |
| 08800048502069 | K200623 | 000 |
| 08800048502076 | K200623 | 000 |
| 08800048502502 | K200623 | 000 |
Trademark Results [OssGuide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSSGUIDE 79273670 not registered Live/Pending |
SK bioland Co., Ltd. 2019-10-23 |
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