The following data is part of a premarket notification filed by Meta Biomed, Co., Ltd. with the FDA for Meta P&bond.
| Device ID | K180802 |
| 510k Number | K180802 |
| Device Name: | Meta P&Bond |
| Classification | Agent, Tooth Bonding, 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-28 |
| Decision Date | 2018-08-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806387894100 | K180802 | 000 |