The following data is part of a premarket notification filed by Eastdent Co., Ltd with the FDA for Smartcord, Smartcord X.
| Device ID | K171577 |
| 510k Number | K171577 |
| Device Name: | Smartcord, Smartcord X |
| Classification | Cord, Retraction |
| Applicant | EASTDENT Co., Ltd 601-1 Sogong B/D, 64 Gugal-ro, Giheung-gu Yongin-si, KR 16972 |
| Contact | Hyonsu Kim |
| Correspondent | Hyonsu Kim EASTDENT Co., Ltd 601-1 Sogong B/D, 64 Gugal-ro, Giheung-gu Yongin-si, KR 16972 |
| Product Code | MVL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-30 |
| Decision Date | 2018-05-03 |
| Summary: | summary |