The following data is part of a premarket notification filed by Meta Biomed Co., Ltd. with the FDA for Md-temp.
| Device ID | K061530 |
| 510k Number | K061530 |
| Device Name: | MD-TEMP |
| Classification | Crown And Bridge, Temporary, Resin |
| Applicant | META BIOMED CO., LTD. 414-12 MOCHOONG-DONG Cheongju City, Chungbuk, KR 361-140 |
| Contact | Tae-hoon Kim |
| Correspondent | Tae-hoon Kim META BIOMED CO., LTD. 414-12 MOCHOONG-DONG Cheongju City, Chungbuk, KR 361-140 |
| Product Code | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-02 |
| Decision Date | 2006-07-21 |
| Summary: | summary |