The following data is part of a premarket notification filed by Meta Biomed Co., Ltd with the FDA for Md-temp Plus.
| Device ID | K190724 |
| 510k Number | K190724 |
| Device Name: | MD-Temp Plus |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | Meta Biomed Co., Ltd 270, Osong Saengmyeong 1-ro, Osong-eup, Heungdeok-gu Cheongju-si, KR 28161 |
| Contact | Suk Song Oh |
| Correspondent | April Lee Withus Group Inc 106 Superior Irvine, CA 92620 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-20 |
| Decision Date | 2019-07-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806387893929 | K190724 | 000 |
| 08806387893912 | K190724 | 000 |
| 08806387893905 | K190724 | 000 |
| 08806387893899 | K190724 | 000 |
| 00818365021031 | K190724 | 000 |